Medical

Proposal to lower the level from 0,05% to 0,001%

 

Formaldehyde is a substance classified as Carcinogen 1B and Skin sensitizer 1. It is listed in Annex II/1577 of Reg. (EC) 1223/2009, so it is forbidden in cosmetic products. However, a number of substances listed in Annex V release formaldehyde in order to achieve a preservative function. For this reason, products containing formaldehyde releaser (FR) preservatives must be labelled with the warning “contains formaldehyde” where the concentration of free formaldehyde in the final product exceeds 0,05%. FR substances are, for example, DMDM Hydantoin, Imidazolidinyl Urea, Diazolidinyl Urea, Polyoxymethylene Urea, Sodium Hydroxymethylglycinate and Glyoxal. Those substances are quite commonly used in nail and hair products.

In 2020 the Commission received additional information suggesting that formaldehyde exposure to levels below 0,05% could cause contact dermatitis in persons with formaldehyde allergy. In the light of data provided, the commission asked in February 2021 the SCCS if the 0,05% threshold for labelling FR substances adequate to protect consumers and if considered necessary to change it.

In May 2021 SCCS published an opinion in response to the Commission request. SCCS stated that the 0,05% threshold is insufficient to protect the formaldehyde-sensitive subjects and proposed to reduce the threshold from 0,05% to 0,001%. This new threshold applies to the total free formaldehyde irrespective of whether a product contains one or more formaldehyde releasers, both for leave-on and rinse-off products.

This new restriction is likely to be adopted soon questioning product formulations containing FRs and new analyses on free formaldehyde will be needed.

THE CLASSIFICATION OF MEDICAL DEVICES (MDCG 2021-24)

 

The classification of medical devices in use by the EU medical device legislation is a risk-based system taking into account the vulnerability of the human body and the potential risks associated with the devices. This approach uses a set of criteria that can be combined in various ways in order to determine classification, e.g. duration of contact with the body, degree of invasiveness, local vs. systemic effect, potential toxicity, the part of the body affected by the use of the device and if the device depends on a source of energy. The criteria can then be applied to a vast range of different medical devices and technologies.

In this guidance is given a general overview on the impact of the classification of medical devices on different aspects of the device’s compliance with the legal requirements:

  • all medical devices must comply with all relevant obligations of the Medical Device Regulation (MDR), however, some requirements depend on the device classification.
  • The technical documentation to be drawn up by the manufacturer must include the risk class of the device and the justification for the classification rule(s) applied in accordance with Annex VIII of the MDR.
  • Demonstrating conformity is in the first instance the responsibility of the manufacturer and for most devices classes the conformity is then assessed by a notified body. The higher the class of the device, the greater the involvement of a notified body in conformity assessment. Annex I (general safety and performance requirements) and Annexes II (technical documentation) and III (technical documentation on post-market surveillance) apply to all devices regardless of class. Further relevant conformity assessment procedures (laid down in Annexes IX to XI) will depend on the class of the device.
  • For any device regardless of class, the manufacturer must ensure the general safety and performance requirements are satisfied (MDR Article 5, MDR Annex I). This includes carrying out a clinical evaluation (MDR Article 5 (3), MDR Article 61, MDR Annex XIV.
  • The manufacturer must update the clinical evaluation with clinically relevant information coming from post-market surveillance, in particular the post-market clinical follow-up.
  • Traceability, for class III implantable devices, economic operators and health institutions are obliged to have a record of the UDI of the devices they have supplied or with which they have been supplied (MDR Article 27). For class II and III devices, the economic operator is obliged to provide information on the Member State(s) where the device is or is to be, made available when registering the device (Annex VI Part A 2.4). In the case of implantable and class III devices, the economic operator must provide a summary of safety and clinical performance (Annex VI Part A 2.14).  For single-use class I and IIa devices packaged and labelled individually, the UDI carrier does not have to appear on the packaging but must appear on a higher level of packaging (Annex VI Part C 4.3).
  • Generally, instructions for use must be supplied together with the device. By way of exception, class I and IIa devices may be supplied without instructions for use if such devices can safely be used without the instructions and no other provisions of Annex I Section 23 state otherwise.

Before applying the classification rules, the manufacturer should first determine if the product concerned, based on its specific medical purpose, falls in the scope of the MDR as a medical device, accessory for a medical device (Article 2 MDR), medical device part or component for replacement (Article 23(2) MDR) or as a device without an intended medical purpose listed in Annex XVI.

It is the intended and not the accidental use of the device that determines the class of the device.

In case several rules, or if, within the same classification rule, several sub-rules, apply to the same device based on the device intended purpose, the strictest rule and sub-rule resulting in higher classification will apply.

In addition to the classification rules set out in Annex VIII of MDR, the manufacturers must also take account of any applicable legal acts and consider guidance documents that may support the classification of their device.

In the guidance are presented explanations of individual rules with different graphical summaries.

Link for the Guidance: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-24_en.pdf

 

 

The Medical Device Coordination Group released a new guidance document regarding the requirements on the quality management system (QMS) to be established by distributors and importers carrying out any of the activities mentioned in points (a)2 and (b)3 of Article 16(2) concerning relabelling and repackaging of devices.

 

Introduction

Article 16(4) of the MDR / IVDR provides for a notified body to certify that the quality management system of the distributor or importer complies with the requirements laid down in the abovementioned Article 16(3). Notified bodies need to establish the assessment activities necessary in order to certify the quality management system of a distributor or importer intended to relabel and / or repackage a device. This guidance document is mainly focused on activities performed by notified bodies, providing also clarification on the quality management system they are expected to assess. A separate MDCG guidance document, in the form of Questions & Answers, is being developed to complement and address implementation of other relevant requirements for distributors and importers introduced by Article 16 of MDR / IVDR.

The scope of this guidance is to provide assistance to notified bodies with regard to certification activities to be carried out according to Article 16(4), attesting that the quality management system of the distributor or importer complies with the relevant requirements.

This guidance is also addressed to distributors and importers in respect to their quality management system to be certified by a notified body.

 

Quality Management System for distributors or importers.

Without prejudice to general obligations that apply to all distributors (Article 14 MDR / IVDR) and importers (Article 13 MDR / IVDR), distributors or importers carrying out any of the activities mentioned in points (a) and (b) of paragraph 2 of Article 16 of the MDR or IVDR are required to ensure that they have in place a quality management system. This quality management system includes procedures, which ensure that the translation of information supplied with the device is accurate and up-to-date. These procedures also ensure that those activities are performed by means and under conditions that preserve the original condition of the device. In addition, they ensure that the packaging of the repackaged device is not defective, of poor quality or untidy. Furthermore, the procedures established under the quality management system should address elements related to contractual relationships to ensure compliance with certain provisions established by Article 16:

  • Contracts with any economic operator the distributor or importer is purchasing the device from should ensure that the distributor or importer is informed in a timely manner about any corrective action taken by the manufacturer in relation to the device in question in order to respond to safety issues or to bring it into conformity with the Regulation;
  • In addition, the contract between the notified body and the distributor or importer should specify the possibility for the notified body to perform on-site audits at the premises of the distributor and importer or their subcontractors if needed, as specified in section 6 of this document.

The quality management system should govern the structure, responsibilities, procedures, processes and management of resources required to implement the principles and actions necessary to achieve compliance with the provisions of Article 16(3) of the MDR / IVDR and is expected to cover and address at least the following:

  • documentation of the management system, including responsibility of the management, and development of policies and procedures, Medical Devices Medical Device Coordination Group Document MDCG 2021-23 Page 4 of 7
  • resource management, including premises and equipment necessary to carry out activities referred to in points (a) and (b) of Article 16(2) as well as selection and control of suppliers and sub-contractors,
  • policies for assignment of activities and responsibilities to personnel ensuring the availability of resources and information necessary to support the operation and monitoring of the activities mentioned,
  • procedures ensuring that the distributor or importer is informed of any corrective action taken by the manufacturer in relation to the device in question in order to respond to safety issues or to bring it into conformity with the Regulation5 (Article 16 paragraph 2 points (a) and (b)),
  • management of corrective actions including procedures for handling non-conforming devices and market recalls due to the activities carried out under point (a) and (b) of Article 16(2), including, when necessary, field safety corrective actions and verification of their effectiveness,
  • procedures to ensure traceability of the devices as well as labels, instructions for use and outer packaging indicating the changes made to the product,
  • control of documents,
  • control of records,
  • supervision of the implementation and maintenance of the quality management system, including internal audits and management review.

 

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Un mese alla scadenza per la presentazione dei dati su Butylparaben

 

Introduzione

Il Regolamento (CE) 1223/2009 sui prodotti cosmetici garantisce un elevato livello di protezione della salute umana stabilendo un sistema di restrizioni e divieti d’uso di determinate sostanze. Il Scientific Committee on Consumer Safety (SCCS) viene incaricato dalla Commissione di effettuare una valutazione del rischio per le sostanze che destano preoccupazioni. In queste valutazioni vengono prese anche in considerazione le proprietà di interferenza endocrina e vengono riportate conclusioni inerenti la sicurezza di un prodotto per i consumatori, incluse le categorie più vulnerabili come i bambini.

 

La Call For Data

A inizio 2019 sono state identificate 28 sostanze per la loro potenziale interferenza endocrina.

La Commissione Europea ha diviso per comodità le sostanze in due gruppi (Gruppo A e Gruppo B) composti da 14 sostanze ciascuno e invitato le parti interessate, ovvero istituti accademici e di ricerca, autorità statali, produttori di cosmetici, produttori delle sostanze interessate e associazioni dei consumatori, a fornire informazioni tossicologiche in possesso inerenti a queste sostanze. I dati raccolti verranno inoltrati al SCCS che provvederà alla loro valutazione. Se necessario la Commissione adotterà le misure necessarie per vietare o limitare l’uso delle sostanze analizzate all’interno dei prodotti cosmetici, informando le persone responsabili e richiedendo il richiamo del prodotto o il ritiro dal mercato o comunque adottando tutti i provvedimenti adeguati a garantire la sicurezza e la salute del consumatore.

La raccolta dei dati per il Gruppo A è iniziata nel 2019 e a inizio 2020 il SCCS si è espresso in merito. In seguito, la commissione ha richiesto ulteriori analisi del rischio per 5 di queste sostanze (4-Methylbenzylidene Camphor (4-MBC), Butylated Hydroxytoluene (BHT), Kojic Acid, Genistein e Daidzein) da eseguire nel corso del 2021.

A febbraio 2021 è iniziata la raccolta dei dati per 10 sostanze del gruppo B (Butylparaben, Methylparaben, Ethylhexyl methoxycinnamate (EHMC)/Octylmethoxycinnamate (OMC)/Octinoxate, Benzophenone-1 (BP-1), Benzophenone-2 (BP-2), Benzophenone-4 (BP-4), Benzophenone-5 (BP-5), BHA/Butylated Hydroxyanisole/Tert-butylhydroxyanisole, Triphenyl phosphate e  Salicylic acid). Le altre 4 sostanze del gruppo sono state escluse dalla raccolta dati a causa di misure normative o discussioni in sospeso che potrebbero pregiudicare la necessità di ulteriori azioni. Il termine per la presentazione dei dati è il 15 novembre 2021.

Fa eccezione il Butylparaben, il cui termine per la presentazione dei dati è stato anticipato al 15 luglio 2021 (fra poco più di un mese) a causa della sua identificazione come Substance of Very High Concern (SVHC) e la sua seguente inclusione nella REACH candidate list of SVHCs a giugno 2020.

Il modulo per l’invio dei dati e la mail di contatto, oltre a maggiori informazioni, sono reperibili qua: click

MDR, Il nuovo regolamento sui dispositivi medici – Cosa cambia?

 

Introduzione

Il regolamento (UE) 2017/745 relativo ai dispositivi medici, anche detto MDR (Medical Device Regulation) entra finalmente in vigore a tutti gli effetti il 26 maggio 2021. Questo articolo vuole mettere in luce le principali novità introdotte con l’MDR, presentando le motivazioni di tali cambiamenti e le conseguenze che ne derivano per coloro che operano nel mondo dei dispositivi medici.

Il Regolamento norma tutte le tipologie di dispositivi medici, compresi gli impiantabili attivi, escludendo solo i dispositivi medico-diagnostici in vitro (normati dal Regolamento Europeo UE 2017/746 (IVDR)). Non solo, il Regolamento si applica anche a quei prodotti che pur non avendo una finalità medica, sono considerati affini ai dispositivi medici per contesto applicativo e per meccanismo di azione sul corpo umano. Tali dispositivi, tra i quali lenti a contatto, apparecchiature per liposuzione, sono elencati nell’allegato XVI del Regolamento. La Commissione europea può aggiornare questo elenco in qualsiasi momento attraverso atti esecutivi. 

L’MDR è sato pubblicato nella Gazzetta ufficiale dell’Unione europea il 5 maggio del 2017, dando il via alla fase transitoria necessaria ai fabbricanti per adeguarsi ai nuovi requisiti. Il periodo transitorio avrebbe dovuto concludersi il 26 maggio 2020, ma a causa della pandemia di COVID-19, il Consiglio Europeo ha posticipato la sua totale attuazione di un anno esatto al 26 Maggio 2021. In questo momento i quattro anni di transizione sono terminati e l’MDR sostituisce a tutti gli effetti la Direttiva 93/42/CEE sui dispositivi medici (MDD) e la Direttiva 90/385 / CEE sui dispositivi medici impiantabili attivi (AIMDD). Quest’ultime, rimarranno valide esclusivamente per i così detti “legacy devices”, ovvero quei dispositivi che sono coperti da un certificato valido in conformità alle Direttive (MDD, AIMDD) e che continueranno a essere legalmente sul mercato in seguito alla data di applicazione di MDR (UE) 2017/745. Questa marcatura CE potrà però rimanere valida solo fino al 26 maggio 2024.

Il Regolamento è un vero e proprio atto legislativo vincolante in tutte le sue parti. Ciò comporta che gli Stati membri dell’UE, sono obbligati a rispettarlo per intero. Al contrario delle Direttive, non sarà, quindi, necessario un provvedimento nazionale di recepimento, dato che il regolamento è immediatamente vincolante ed obbligatorio verso tutti i soggetti pubblici o privati, tenuti al rispetto del diritto dell’UE.

 

Obiettivo del nuovo regolamento UE

Il Regolamento è una revisione sostanziale delle precedenti direttive allo scopo di stabilire un quadro normativo solido, trasparente, prevedibile e sostenibile per i dispositivi medici, che garantisca un livello elevato di sicurezza e di salute sostenendo nel contempo l’innovazione. Entrambi i Regolamenti (MDR e ) prevedono un rafforzamento significativo delle norme che regolano gli aspetti della vigilanza e della sorveglianza post-commercializzazione durante l’intero ciclo di vita del prodotto.

Nello specifico, i principali obiettivi del nuovo MDR 2017/745 sono:

  • appianare le divergenze nei vari sistemi regolatori nazionali tra i diversi Stati membri dell’Unione Europea;
  • potenziare il controllo sulle aziende da parte degli Organismi Notificati (ON);
  • rafforzare la sorveglianza post-market;
  • identificare e tracciare meglio i dispositivi medici;
  • far fronte alla rapida e necessaria immissione sul mercato dei prodotti più innovativi

 

Di seguito evidenziamo le principali novità:

Classificazione e valutazione della conformità

Il nuovo regolamento impone delle regole di classificazione più severe rispetto al MDD, comportando per alcuni DM una possibile riclassificazione, specialmente per determinati tipi di prodotti come dispositivi medici a base di sostanze e software. A queste due categorie molto spesso veniva attribuita la classe di rischio più bassa, la classe I, cioè quella classe per la quale per immettere in commercio un dispositivo medico è sufficiente un’autodichiarazione da parte del fabbricante, senza richiedere l’intervento di un Organismo Notificato.

L’eventuale riclassificazione di un prodotto verso una classe di rischio superiore significa dover disporre di maggiori risorse e nuovi adempimenti che non sempre rientrano nella disponibilità di piccole e medie imprese.

 

La sorveglianza post-commercializzazione e l’introduzione di EUDAMED

Se nella precedente Direttiva la documentazione tecnica era focalizzata sugli aspetti di progettazione e realizzazione del dispositivo, il Regolamento vuole includere in tale documentazione anche tutte le attività di convalida del prodotto e del processo produttivo e le attività con risvolti clinici, tra cui la valutazione clinica ed il piano di follow-up clinico post-commercializzazione.

Il concetto alla base è che i prodotti devono soddisfare i requisiti normativi non solo al momento dell’immissione sul mercato, ma anche durante l’intero ciclo di vita del prodotto.

Il Regolamento obbliga ogni fabbricante ad organizzare un sistema di sorveglianza post-commercializzazione (PMS) che comprenda attività reattive (quali ad esempio attività di vigilanza, gestione dei reclami, revisione e analisi di dati clinici di letteratura e database) e attività proattive (questionari/interviste agli utilizzatori, studi clinici, studi clinici di post-market clinical follow-up (PMCF)), imponendo così di verificare il comportamento clinico del dispositivo medico anche nelle sue reali condizioni di utilizzo.

Il MDR stabilisce che siano resi disponibili pubblicamente sia un documento riassuntivo dei dati di sicurezza e performance clinica, sia i risultati delle indagini cliniche condotte con il dispositivo medico.

Lo strumento utilizzato per rendere disponibili anche al cittadino i dati clinici dei dispositivi medici sarà la banca dati EUDAMED (European Databank on Medical Devices).

L’obiettivo di EUDAMED è migliorare la trasparenza, raccogliendo ed elaborando le informazioni riguardanti i dispositivi medici presenti sul mercato, i relativi certificati emessi dagli Organismi Notificati, le indagini cliniche condotte coi dispositivi, i ruoli degli operatori economici che fanno parte della filiera del dispositivo, la vigilanza e la sorveglianza. Tutte queste informazioni saranno contenute in EUDAMED attraverso la suddivisione in 6 moduli interconnessi, ma l’obbligo di utilizzo della banca dati partirà solo quando tutti i suoi moduli saranno disponibili. Attualmente è disponibile solo il modulo di registrazione per gli Operatori Economici.

Il nuovo strumento introdotto dal Regolamento per soddisfare la tracciabilità del dispositivo medico è il codice unico identificativo UDI (Unique Device Identification): una serie di caratteri numerici o alfanumerici che dovrà essere riportato sull’etichetta del dispositivo e su tutti i livelli esterni di confezionamento e nella dichiarazione di conformità UE. Il codice UDI permetterà, a livello europeo, la continua identificazione e tracciabilità del dispositivo durante l’intero ciclo di vita.

 

La persona responsabile del rispetto della normativa

 

Il regolamento richiede che il fabbricante garantisca che la supervisione e il controllo della fabbricazione dei dispositivi medici, nonché le attività di vigilanza e sorveglianza post-commercializzazione ad essi relative, vengano effettuati all’interno dell’organizzazione da una persona responsabile (PR) del rispetto della normativa in possesso di requisiti minimi di qualificazione (Articolo 15 dell’MDR).

La PR dovrà possedere le competenze necessarie per supportare il fabbricante per tutti gli aspetti riguardanti la conformità normativa. Tale figura può essere interna o esterna, in relazione alla dimensione dell’Impresa.

 

Sistema di gestione per la qualità

 

L’MDR esplicita l’obbligo del fabbricante di operare secondo un sistema di gestione per la qualità (articolo 10 del MDR) che sia conforme al regolamento e sia proporzionato alla classe di rischio e alla tipologia di dispositivo. Nonostante sia un vantaggio essere certificati secondo la norma ISO 13485 (Medical devices – Quality management systems -Requirements for regulatory purposes), tale certificazione non è obbligatoria e non garantisce l’automatica conformità al MDR.

Il sistema di gestione della qualità riguarda tutte le parti e gli elementi dell’organizzazione del fabbricante che si occupano della qualità di processi, procedure e dispositivi. Esso disciplina la struttura, le competenze, le procedure, i processi e le risorse gestionali richiesti per attuare i principi e le azioni necessari a conseguire il rispetto delle disposizioni del regolamento.

 

Conclusione

 

L’MDR vuole essere una soluzione contemporanea e uniforme per la gestione della qualità e il rilascio sul mercato europeo di dispositivi medici.

Sebbene le implementazioni richieste dal nuovo regolamento siano sviluppate al fine di garantire la qualità e la sicurezza dei dispositivi medici al contempo possono rappresentare degli ostacoli per le piccole e medie imprese, le quali proprio per adempiere alle nuove richieste si potrebbero trovare a dover stravolgere l’intero processo produttivo.

Inoltre, è importante considerare che ad oggi gli Organismi Notificati certificati secondo MDR sono 20, un numero esiguo rispetto ai più di 50 certificati secondo Direttiva. Questo aspetto comporta la dilatazione dei tempi richiesti per ottenere la certificazione e poter immettere sul mercato un dispositivo medico. Tale ritardo, così come riportato anche dalle diverse associazioni di settore, avrà un impatto negativo in particolare, sulla possibilità di rendere disponibili dispositivi medici innovativi.

Nonostante l’ampliamento del periodo di transizione dovuto al particolare momento storico che stiamo affrontando e al mancato completamento di importanti attività (e.g. Eudamed, Numero ON) l’MDR porta con sé molte innovazioni che cercano di tenere il passo con lo sviluppo tecnologico ma che al contempo cercano di sopperire alle criticità emerse durante l’applicazione negli ultimi due decenni delle Direttive.

Harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional

 

The Medical Device Coordination Group has released a revision of the guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional.

This is especially helpful since the MDR fully applies by the 26th May, implying that the obligations regarding EUDAMED need to be met.

 

Introduction

Article 33 of Regulation (EU) 2017/745 on medical devices (MDR) requires the Commission to set up a European database on medical devices (‘EUDAMED’).

The same article states that Eudamed will be composed of six different electronic systems (modules), which facilitate the collation and processing of information under the MDR regarding the registration of relevant economic operators (actor registration), devices and systems and procedure packs (UDI), notified bodies & certificates, certain aspects of conformity assessment, clinical investigations, vigilance and market surveillance as well as post-market surveillance.

On 30 October 2019, the Commission published a notice by which it concluded that the full functionality of EUDAMED requires the availability and full operation of all six modules, both individually and jointly. The notice foresees the launch of EUDAMED for May 2022, which correlates with the date of application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices3 (IVDR).

Article 123(d) MDR addresses the possibility that EUDAMED is not fully functional on the date of application of the MDR (26 May 2021). Accordingly, the obligations and requirements in the MDR that relate to EUDAMED shall apply from the date corresponding to six months after the date of publication of the notice referred to in Article 34 – notice of full functionality of Eudamed. Until EUDAMED is fully functional, the MDR stipulates that the corresponding provisions of Directives 90/385/EEC4 and 93/42/EEC5 shall continue to apply for the purpose of meeting the obligations laid down in the provisions of Article 123(d) regarding the exchange of information.

In addition, Article 123(e) MDR clarifies that Article 29 MDR on the registration of devices, and Article 56 MDR on the registration of certificates, start to apply 24 months after the date of publication of the notice referred to in Article 34 MDR.

 

Scope

This document provides guidance to Member States and other relevant parties on the application of certain MDR provisions during the absence of EUDAMED. To that end, this guidance intends to describe harmonised administrative practices and alternative technical solutions for the exchange of information until EUDAMED becomes fully functional.

The proposed practices and solutions aim to enable Member States and other relevant parties to meet their obligations under the MDR effectively while minimising any potential additional burden on the parties concerned.

This guidance addresses in particular cases where the exchange of information would be difficult, or even not possible, to achieve based on the corresponding provisions of the Directives. This guidance takes into account the decision of the MDCG that the Commission makes available to Member States each EUDAMED module as soon as it is operational. This approach also has an impact on the means by which relevant information collected under the MDR will be made available to the public, which shall take place on a gradual basis.

The proposed practices and solutions set out in this document do not affect the general obligations of the parties to comply with the requirements under the MDR, including those contained in the provisions referred to in Article 123 letters (d) and (e) MDR.

Whenever this guidance makes reference to CircaBC as alternative solution, the Commission and other relevant parties should endeavour to make use of already existing CircaBC directories to the extent that this is possible and appropriate.

Parties should also take note of the MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States.

 

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ISO 20417:2021 Medical devices – Information to be supplied by the manufacturer

 

Introduction

In April 2021 the new ISO 20417 Medical Devices – Information to be supplied by the manufacturer was published.

This document provides the requirements for the identification and labels, the packaging, marking of a medical device or accessory, and accompanying information. The aim of the standard is to serve as a central source of these common, generally applicable requirements, allowing each specific product standard or group standard to focus more concisely on the unique requirements for a specific medical device.

The standard can be  helpful to medical device manufacturers by:

  • Enabling them to comply with the requirements of the MDR
  • Facilitate to enter new markets and trade
  • Manage more effectively the associated risk

 

It is to be noted that in case of a conflict or when a specific product standard or a group standard exists, this document should not be used separately. Specific requirements of medical device product standards or group standards take precedence over requirements of this document. But unless specified otherwise, the general requirements of this document apply.

 

Scope

This document specifies the requirements for information which need to be supplied by the manufacturer for a medical device or an accessory. The standard includes the generally applicable requirements for identification and labels, the packaging, marking of a medical device or accessory, and accompanying information. Please note that this document does not specify the means by which the information is to be supplied.

 

 

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The Medical Device Coordination group has released a questions and answers document regarding the transitional period lasting untill May 2022 when the IVDR becomes fully applicable.

 

The document highlights the possible course of action for notified bodies in the absence of expert panels and EU reference laboratory (EURL), which might be necessary to involve for certifying a class D in vitro diagnostic medical device. Since according to the IVDR (Regulation (EU) 2017/746 on in vitro diagnostic medical devices), as part of conformity assessment of class D in vitro diagnostic medical devices (IVDs), the manufacturer must submit an application to a notified body. In addition to the assessment by the notified body, under certain conditions particular elements may be reviewed by an expert panel and/or tested by an EU reference laboratory (EURL).

The document provides the following Q&As:

Q1. During the transition period, may notified bodies accept applications from manufacturers for certification of class D IVDs, and issue the corresponding certificates, if the IVD expert panel is not yet operational?

Notified bodies may accept and begin the assessment of applications for class D IVDs. However, the notified bodies may not issue the certificate before the expert panel is operational and, for the devices that require consultation of the panel, before the panel has provided its views (see also Q2 and Q3).

 

Q2. For devices to which this requirement is applicable, when must the notified body submit the performance evaluation report of the manufacturer to the expert panel?

According to IVDR Art 48(6), “the notified body shall provide the performance evaluation report of the manufacturer to the expert panel within five days of receiving it from the manufacturer”. If the panel is not yet operational, the notified body should submit the performance evaluation report of the manufacturer within five days of the panel becoming operational.

 

Q3. How should the notified body determine whether the device will have to undergo consultation of the expert panel prior to issuing the certificate?

According to IVDR Article 48 (6), “where no CS are available for class D devices and where it is also the first certification for that type of device, the notified body shall consult the relevant experts referred to in Article 106 of Regulation (EU) 2017/745 on the performance evaluation report of the manufacturer”. MDCG guidance is in preparation on what constitutes a “type of device”, as well as on  As announced on the process that the notified bodies should follow to determine whether a given certification is the first one for that type.

 

Q4. When can the notified body expect to receive the views of the expert panel?

According to IVDR Article 48(6), “The experts shall provide their views to the notified body within the deadline for delivery of the scientific opinion by the EU reference laboratory”. If no EU reference laboratory (EURL) is designated for the device in question, the expert panel should provide its views within 60 days, in line with the time available for the EURL to issue its opinion according to Section 4.9 of Annex IX and Section 3 (j) of Annex X.

 

Q5. During the transition period, may notified bodies accept applications from manufacturers for certification of a class D IVD, and issue the corresponding certificate(s), if an EURL is not designated for that device?

During the transition period, as long as no EURL has yet been designated for that specific device, category or group of device, the notified bodies may accept applications for a class D IVD and issue the corresponding certificate(s).

 

Q6. What will happen to devices certified under the IVDR in the absence of an EURL if an EURL is designated for the corresponding scope at a later time point?

The certificate will remain valid until its expiry date established by the notified body and according to the IVDR. On sample or batch testing, the notified body and manufacturer should follow the EURL related  provisions of Section 4.12 of Annex IX or Section 5 of Annex XI from the time that the EURL becomes operational. For performance verification, the notified body should follow the EURL-related provisions of Section 4.9 of Annex IX or Section 3 (j) of Annex X at the time of the re-certification in line with Section 4.11 (f) of Annex VII. So, the procedure set out in paragraph 5 of Article 48 involving an EURL will be applied at the time of the re-certification.

 

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What you need to know about the new EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR), and their implementation in Northern Ireland.

 

Brexit is official, the United Kingdom has left the European Union. But what does that mean for Northern Ireland? In Northern Ireland, the CE mark remains valid, so CE marked devices can be placed on the market and they fall under the jurisdiction of the European Court. Whereas market surveillance will be performed by the UK Medicines and Healthcare products Regulatory Agency (MHRA).

Non-EU companies wanting to take part in the European market can keep relying on an Authorized Representative based in Northern Ireland for placing their devices on that market as well as the rest of the EU. But who can place Medical Devices on the Northern Ireland market? Only an importer based in Northern Ireland can do that, but the UK Responsible Person (UKRP) may be based anywhere in the UK.

Regarding the subject the UK Medicines and Healthcare products Regulatory Agency (MHRA) published a new version of their guidance document for placing devices on the Northern Ireland market. The document clarifies the roles of the importer, distributor, and manufacturer by directly referencing the Medical Devices Regulation (MDR) and the In-vitro Diagnostic Medical Devices Regulation (IVDR), meaning that the importer must comply with Article 13, distributors must comply with Article 14 and manufacturers or their Authorized Representative (AR) must comply with Article 15 regarding the Person Responsible for Regulatory Compliance. All these requirements will apply when the MDR/IVDR become fully effective, for the MDR that date is May 26, 2021 and for the IVDR May 26, 2022. The guidance documents also specifies that Northern Ireland based distributors, such as drugstores or supermarkets my be acting as importers.

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The Medical Device Coordination Group has released a Guidance on state of the art of COVID-19 rapid antibody tests.

 

The Coronavirus pandemic is still going strong and thus the demand for rapid antibody tests is high, especially since they have become more accessible to the broad public being sold in local drugstores and supermarkets.

Making sure that the devices’ performances are adequate is not a simple task, the directive 98/79/EC on in vitro diagnostic medical devices establishes that devices must be designed and manufactured in such a way that they are suitable for the intended purpose specified by the manufacturer, taking into account the generally acknowledged state of the art.

The MDCG guidance intends to establish particular elements on the current state of the art for COVID-19 rapid antibody tests. Specifying that in this particular context, the state of the art may be seen as the minimum expected from devices being placed on the market at the time of publication of this document.
It is crucial that the manufacturer clearly specifies the device’s intended purpose, considering what levels of performance are needed and what aspects of the state of the art are relevant. Keeping in mind to continuously update/revise the device’s performance data and/or adjust the intended purpose with new available data.

The Legal requirements of Directive 98/79/EC on device performance:

Devices must achieve the relevant performance, in particular in terms of analytical sensitivity, diagnostic sensitivity, analytical specificity, diagnostic specificity, accuracy, repeatability, reproducibility, including control of known relevant interference, and limits of detection, stated by the manufacturer.
For COVID-19 devices it is always necessary to define the intended purpose, the intended purpose must be specified in the instructions for use and/or on the label.
Including aspects such as:
• the intended user,
• the target population,
• window between infection and antibody detection,
• result interpretation (including limitations of interpretation),
• assay design (target antigen(s), antibody types)9,
• limitations of the assay,
• whether the assay is intended, for example, to detect the antibody response in individual patients’ recovery, to assess if the patient has been previously infected, to assess response to vaccination,
• the exclusion of antibody test use as first line test for diagnosis.

It is also required that the instructions for use describe the performance of the device with regard to the non-exhaustive parameters listed above and that the technical documentation contains adequate performance evaluation data showing the performances claimed by the manufacturer. The data should originate from studies conducted in an environment targeted by the assay (e.g. clinical settings) or result from relevant references. The information on the establishment of performance should be complete to allow an assessment of its quality.
For biological analytes such as virus specific antibodies there is no reference procedure of higher order. Therefore, the performance evaluation should be done in direct comparison to diagnostic device(s) measuring the same analyte which are estimated as reflecting the “state of the art” at the time of the performance study (reference devices). Samples with discrepant test results obtained for the device under evaluation and reference (comparator) device should undergo further investigation (e.g. further assays, patient history) to clarify the probable “true” status, as far as possible.

The State of the art:

102 instructions for use of COVID-19 rapid antibody tests placed on the European market before September 2020 were examined. Performance criteria/considerations for devices used for the detection of antibodies against SARS-CoV-2 published by different sources, including the WHO, were also reviewed. The outcome of this analysis was used as a basis for the following findings:

1) Performance evaluation modalities
The performance should be ideally evaluated for each claimed clinical specimen type unless equivalence between the relevant biological matrices has been demonstrated.
• Interference studies: Standard interference studies should be performed and should take into account the typical potential sources of interference in the sample matrix in question. Please refer to pages 25-26 of the following document ‘Current performance of COVID-19 test methods and devices and proposed performance criteria – Working document of Commission services’ for more information.12
• Cross reactivity studies: samples from patients with infection history of related viruses, e.g. SARS-CoV-1, MERS-CoV, human common cold coronaviruses, or other respiratory infections (including influenza). Please refer to pages 25-26 of the following document ‘Current performance of COVID-19 test methods and devices and proposed performance criteria – Working document of Commission services’ for more information.
Note: Antibodies for other respiratory infection agents are considered as potentially pertinent cross reacting agents to be systematically tested in addition to other more usual cross reactants. As part of post market surveillance, it remains the responsibility of the manufacturer to continuously monitor the performance of their devices, including for new potentially cross-reacting agents and update their relevant documentation, where necessary.
• Diagnostic sensitivity evaluation:
The positive sample panel should include at least 200 samples from individuals with a confirmed diagnosis of a SARS-CoV-2 infection with details on timing between sampling and potential onset of symptoms.
Considering that diagnostic sensitivity depends highly on the time interval between the contact with the virus and sample taking, diagnostic sensitivity studies should use samples at various stage and severity of disease and from putative infections. Samples could be longitudinal, drawn at different times from the same individuals. The positive sample panel should include early and later samples homogenously distributed in terms of the time interval between contact with the virus and sample taking.
Depending on the intended purpose of the device, it may be difficult to get access to well-defined panels reflecting the full diversity of potential antibody responses, representing e.g. different time points after infection, different follow-up courses of infection, asymptomatic / symptomatic infection, etc. Therefore, an option may be to use the device in parallel with an established device13 to investigate a representative set of samples, without preselection or exclusion of specimens, from a high incidence situation such as from a local or regional outbreak or from hospitals.
• Diagnostic specificity evaluation:
The negative panel should include at least 200 samples.
The negative panel should consist of samples derived either from patients tested for antibodies for SARS-CoV-2 and confirmed as negative, or samples collected prior to November 2019.
The negative samples should broadly represent the different factors present in the target population according to the intended purpose of the device. Age, gender, demographics and additional factors such as previous disease history (e.g. non-SARS-CoV-2 respiratory tract infections) or long-term medication of the patient should be considered.

2) Diagnostic performance of the device
Diagnostic sensitivities mentioned in the studied IFUs were heterogeneously determined, making it difficult to conclude on a minimum value reflecting the state of the art for this performance. It should nevertheless be noted that performance criteria/considerations published by different sources, including the WHO, for devices used for the detection of antibodies against SARS-CoV-2 generally require at least 90% diagnostic sensitivity for each antibody type (IgM, IgG or total Ig).
In the case of diagnostic performance established by comparison with a device used as reference, the diagnostic sensitivity should be at least equivalent to reference device(s), see Section “Legal requirements of Directive 98/79/EC on device performance”.
Diagnostic specificity should be at least 98%.
Confidence intervals should be provided for the estimates of both the diagnostic sensitivity and diagnostic specificity, 95 % confidence intervals are recommended.

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For reference see also: Current performance of COVID-19 test methods and devices and proposed performance criteria – Working document of Commission services

VISITA IL SITO: mdcg_2021-2_en.pdf