#medical devices Tag

28 Nov

Posted at 10:41h in Medical

Where we stand with MDR and IVDR

European regulations about Medical Devices (Reg. EU 2017/745) and In-vitro Diagnostics (Reg. EU 2017/746), since their publication in 2017, have undergone several extensions. Initially due to COVID-19 pandemic and then because of the lack of an adequate number of Notified Bodies, which are appointed to the evaluation and approval for MD and IVD technical files. Those delays have potential impacts on Medical Devices and In-vitro Diagnostics availability for end-users.

With last extensions approved by European Commission, it is expected that new Medical Devices and In-vitro Diagnostics produced and made available on the market will be compliant no longer with the Directive, but only with the Regulation no later than 2029.

 

What is new about DEHP

In order to line up with new extensions, on November 13th, 2023, the European Commission published Regulation (EU) 2023/2482, which modified the Annex XIV of Regulation (EC) 1907/2006 (REACH).

This regulation extends the latest application date for authorization to use Bis(2-ethylhexyl) phthalate (DEHP) in Medical Devices and In-vitro Diagnostics.

DEHP is a phthalate used ad plasticizer and is listed in Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation) as a Repr. 1B (H360FD) substance and is known to be an Endocrine Disruptor.

Previously, latest date for application and sunset date for authorization were November 27th, 2023, and May 25th, 2023, respectively.

With the new regulation, these deadlines will be extended until January 1st, 2029, for latest application date and July 1st, 2030, for sunset date for application.

This means that producers which want to have DEHP inside products have time until January 1st, 2029, to forward their request for authorization to use DEHP and have to receive a positive response by July 1st, 2030, otherwise their will not be allowed anymore to use it in their Medical Devices or In-vitro Diagnostics.

These new deadlines will allow stakeholders to manage properly registration of their devices and guarantee a full compliance with a better safety for the end-consumers.

For more information about the compliance of your Medical Device or In-vitro Diagnostic with all European regulations, contact our expert at chemsafe@chemsafe-consulting.com

 

Sources:

https://echa.europa.eu/en/authorisation-list/-/dislist/details/0b0236e1807e0026

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202302482

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18 Jul

Posted at 10:25h in Medical

Harmonized Standards:

The Summary of the references of the harmonized European standards was published in the Official Journal of the European Union, in support of Regulation (EU) 2017/745 on medical devices and of Regulation (EU) 2017/746 on medical devices in vitro. New Commission Implementing Decision (EU) 2023/1410 has been released amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for sterilization of health care products (EN ISO 25424:2019) and biological evaluation of medical devices (EN ISO 10993-10:2023).

 

For more information: https://health.ec.europa.eu/medical-devices-topics-interest/harmonised-standards_en

 

Unique Device Identifiers for contact lenses:

The EU Commission has published a Delegated Regulation amending Regulation (EU) 2017/745 of the European Parliament and of the Council, as regards the assignment of Unique Device Identifiers for contact lenses.

In order to resolve implementation issue and allow a proportionate UDI-DI (the identifier specific to a manufacturer and a device) data entries in Eudamed, the “Master UDI-DI” has been developed by the Commission. Master UDI-DI is intended as the identifier of a group of highly individualised devices (i.e. contact lenses) presenting specific similarities with respect to defined clinically relevant parameters. In the future the Master UDI-DI solution could be extended to a other highly individualised devices.

 

For more information: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=PI_COM:Ares(2023)2068096&utm_source=QualityMedDev&utm_campaign=6251345263-EMAIL_CAMPAIGN_2021_09_05_08_08_COPY_01&utm_medium=email&utm_term=0_7b44d626e2-6251345263-233168890&mc_cid=6251345263&mc_eid=f01fefd851

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13 Jun

Posted at 09:24h in Medical

Il Comitato Scientifico per Sicurezza dei Consumatori (SCCS) è incaricato di valutare la sicurezza e i rischi associati ai prodotti di consumo non alimentari (cosmetici, giocattoli, tessili, prodotti per la cura della persona e della casa) e viene consultato dalla Commissione Europea qualora sorgano dubbi sulla sicurezza di uno o più ingredienti cosmetici.

 

Cosa sono le SCCS Notes of guidance for the testing of cosmetic ingredients and their safety evaluation:

Il Comitato, regolarmente, aggiorna le Notes of guidance, un documento contenente informazioni rilevanti sulla valutazione di sicurezza degli ingredienti e dei prodotti cosmetici. La 12a e ultima revisione è stata pubblicata il 16 maggio 2023 e va a sostituire l’11a revisione uscita circa un anno e mezzo prima.

Le Notes of guidance sono linee guida, per cui non è obbligatorio rispettare quanto riportato nella valutazione dei prodotti cosmetici. Tuttavia, rappresentano uno degli approcci maggiormente utilizzati nella stesura del Cosmetic Product Safety Report (CPSR) oltre che un’importante fonte di dati per ciò che riguarda il calcolo dell’esposizione ai prodotti cosmetici. Inoltre, qualora vi sia la necessità di fornire dati all’SCCS per la valutazione di un ingrediente, gli studi richiesti e il formato del report sono quelli indicati nel documento.

 

Novità della 12a Revisione:

Gli argomenti sviluppati nella nuova revisione sono:

  • Importanza della revisione sistematica della letteratura;
  • Aggiornamento dei metodi alternativi
  • Importanza dell’Adverse Outcome Pathway (AOP), dei Defined Approaches (DAs), degli Integrated Approaches to Testing and Assessment (IATA), del Next Generation Risk Assessment (NGRA) con le definizioni di Bioacivity Exposure Ratio (BER), Threshold of Toxicological Concern (TTC) e di internal Threshold of Toxicological Concern (iTTC)
  • Aggiornamento sui possibili metodi di predizione in silico
  • Revisione dei dati di esposizioni, in particolare i modelli, i parametri specifici per la via inalatoria e l’esposizione aggregata
  • Esposizione dei bambini ai prodotti cosmetici secondo l’età
  • Razionale dei dati di esposizione ai prodotti solari
  • Human biomonitoring (HBM) e differenze con l’approccio al risk assesment dell’SCCS
  • Obblighi di segnalazione per le sostanze cancerogene, mutagene e reprotossiche (CMR)
  • Sostanze attive endocrine, introduzione della non-monotonic dose response e obblighi di segnalazione
  • Template per il modello descrittivo del Physiologically Based ToxicoKinetics, analisi e verifica dei parametri

In generale, si può notare una maggiore attenzione riguardo l’utilizzo di metodi alternativi e la predizione in silico, trend già presente nelle precedenti revisioni; ed una maggiore attenzione riguardo la valutazione delle sostanze classificate come Endocrine Disruptor. Si evidenzia, inoltre, l’inserimento di una nuova sezione dedicata all’esposizione dei prodotti cosmetici nei bambini, in particolare ai potenziali fattori di rischio da tenere in considerazione.

 

Il documento originale può essere consultato al presente link: https://health.ec.europa.eu/latest-updates/sccs-notes-guidance-testing-cosmetic-ingredients-and-their-safety-evaluation-12th-revision-2023-05-16_en

 

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29 Nov

Posted at 10:32h in Medical

What is a claim:

Claim is a slogan or description of the product that allows you to present the product itself to the customer, focusing attention on the main features, allowing him to choose the most suitable cosmetic product for his needs and for the company to stand out in the market.

 

Reference regulation:

For this reason, to avoid untrue or misleading words that prevent the customer from making an informed choice and that provide an improper advantage to the company, even the claims that can be applied on the labels of cosmetic products are governed by a specific regulation.

The reference regulation is Reg. (EC) 655/2013 ” laying down common criteria for the justification of claims used in relation to cosmetic products” and in particular its only annex, which groups together the common criteria that must comply with the claims of cosmetics product.

 

Common criteria for claims:

The common criteria are divided into six points:

  1. Legal compliance

For cosmetic products no registration or authorization by the authorities are needed. For this reason, claims such as “authorized by the European Commission” or “Registered Cosmetic” are not allowed. Similarly, it is not allowed to use claims that may give the impression of a particular benefit, if this benefit is a legal requirement. For example, the claim “Not tested on animals” is not allowed because animal testing for cosmetic products and their ingredients is prohibited by the European regulation, or “Without formaldehyde” since every cosmetic product must be formaldehyde-free as an ingredient prohibited within cosmetic products.

  1. Truthfulness

If the presence of a specific ingredient is declared or a specific property of an ingredient is reported, the finished product must contain that specific ingredient or having that property itself. For example, it is not possible to report “With lemon juice” if only lemon flavor is present or “With moisturizing plant extracts” if the finished product does not have moisturizing properties. Then, commercial messages must not give the impression that the opinions expressed are verified statements, unless they are supported by verifiable evidence.

  1. Evidential support

This section establishes some criteria regarding the studies and evidence that must be presented in support of a claim. It is also specified that for claims that are clearly exaggerated or abstracted, there is no need for supporting evidence. For example, the claim “For hair as soft as a cloud” does not need proof because it is an abstracted and exaggerated comparison.

  1. Honesty

The presentation of a product’s performance should not go beyond the available supporting evidence. Furthermore, specific characteristics cannot be attributed to the product if similar products possess them and the specific conditions to which the action of a product is linked must be declared. For example, if the anti-wrinkle effect of a cream is bound to the simultaneous use of a face serum, then it must be specified. Writing “This cream makes your skin younger” is incorrect, as the consumer does not perceive that he also needs the serum to benefit from the declared effects.

  1. Fairness

Product claims must not disparage competing products or create confusion with them. For example, “Without acidic ingredients that can irritate the skin” is disparaging towards competitive products that contain them.

  1. Informed decision-making

Marketing communications shall take into account the capacity of consumers to understand the messages and be easily understandable. Furthermore, the claims are an integral part of the products and shall contain information that allows the average end user to make an informed choice.

 

For more information:

REGULATION (EU) N. 655/2013

https://eur-lex.europa.eu/legal-content/IT/TXT/?uri=CELEX%3A32013R0655

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07 Nov

Posted at 10:44h in Medical

MDR con il freno tirato. Nonostante sia passato poco più di un anno dall’entrata in vigore del Regolamento (UE) 2017/745 dei dispositivi medici molte delle variazioni introdotte non sono ancora del tutto entrate a regime. Basti pensare, per esempio, alla banca dati europea Eudamed, che avrebbe dovuto essere pienamente operativa in concomitanza all’entrata in vigore del Regolamento stesso, quindi a partire dal 26 maggio 2021. Eudamed sarà costituita da un sito pubblico e da sei moduli interconnessi (registrazione operatori economici; registrazione UDI e dispositivi; organismi notificati e certificati; indagini cliniche e studi delle prestazioni; vigilanza e sorveglianza post-commercializzazione; sorveglianza del mercato). “Sarà” perché ad oggi solo i primi tre moduli sono stati resi disponibili; la piena funzionalità di Eudamed avverrà in contemporanea solo quando i diversi moduli avranno raggiunto la piena funzionalità e saranno stati sottoposti ad audit indipendenti. Nell’ultima timeline presentata dalla Commissione europea (giugno 2022) il rilascio di Eudamed è previsto tra il primo e l’ultimo quadrimestre del 2024.

 

Il nodo Eudamed:

Tutti gli operatori economici, cioè fabbricante, mandatario, importatore e produttori di sistemi e kit procedurali, saranno, quindi, tenuti a registrarsi nella banca dati europea Eudamed, prima dell’immissione sul mercato di un dispositivo diverso da uno su misura. Gli obblighi e i requisiti dei regolamenti (MDR e IVDR) relativi a Eudamed si applicheranno, però solo, a decorrere dalla data corrispondente a sei mesi dalla pubblicazione nell’Official journal of the european union (Ojeu) dell’avviso della piena funzionalità di Eudamed.

 

Resta l’obbligo di iscrizione alla banca dati nazionale…

Per gli operatori economici interessati, è possibile procedere, in modo volontario, alla registrazione, al fine di ottenere il numero di registrazione unico (SRN) e familiarizzare con l’utilizzo di Eudamed. Per gli stessi moduli resi accessibili è disponibile la corrispettiva sezione aperta al pubblico. In ogni caso è bene tenere a mente che ad oggi la registrazione in Eudamed e l’ottenimento del SRN non sostituiscono l’obbligo di adempiere alla registrazione nella banca dati nazionale. Nei prossimi mesi di uso del sistema su base volontaria, è, infatti, prevista la doppia registrazione in Eudamed e nella banca dati italiana. Come indicato all’interno dei decreti legislativi 137 e 138 del 5 agosto 2022, nel corso di questa fase, il Ministero garantisce l’implementazione di misure informatiche al fine di assicurare la connessione tra Eudamed e le banche dati esistenti o in via di implementazione, in conformità al sistema unico di identificazione del dispositivo (UDI), tenendo in considerazione anche la gestione dei legacy devices.

 

… anche per i distributori

In materia di registrazione degli operatori economici si evidenzia una differenza tra la banca dati europea Eudamed e la banca dati italiana per quanto riguarda la figura del distributore. Come indicato, infatti dai decreti legislativi 137 e 138, viene confermato l’obbligo di registrazione presso la banca dati del Ministero della Salute sia per i fabbricanti di dispositivi su misura sia per i distributori che mettono a disposizione dispositivi, diversi dai dispositivi su misura, sul territorio italiano.

 

Organismi notificati sotto pressione:

Un’altra criticità derivante dall’applicazione di questa nuova legislazione è rappresentata dall’esponenziale incremento di lavoro a cui sono sottoposti gli Organismi notificati (Nb), cioè quelle organizzazioni accreditate per il rilascio della conformità dei dispositivi medici in accordo al Regolamento 2017/745 (MDR), al quale si contrappone l’esiguo numero di Nb. I fabbricanti di dispositivi medici si ritrovano così a dover gestire tempi lunghi, nella migliore delle ipotesi, al fine di ottenere le certificazioni. Nel peggiore dei casi non hanno la certezza di poter certificare il proprio dispositivo prima della scadenza del certificato secondo Direttiva 93/42 (MDD). Questo aspetto ha ripercussioni sull’intera filiera, rischiando di rendere irreperibili molti di prodotti.

 

Si teme per la disponibilità di devices sul mercato:

La disponibilità sul mercato dei dispositivi medici è un tema decisamente attuale e critico, al punto che, ad agosto, anche il Medical Device Coordination Group (MDCG) ha sviluppato il documento “MDCG 2022-14 Position Paper Transition to the MDR and IVDR Notified body capacity and availability of medical devices and IVDs”, che indica una serie di azioni specifiche per incrementare la capacity degli Organismi notificati, consentirne l’accesso da parte delle imprese e promuovere la preparazione dei fabbricanti al fine di agevolare la transizione ai Regolamenti (UE) 2017/745 e 2017/746. Il documento risponde, infatti, all’esigenza di garantire la presenza sul mercato di dispositivi medici sicuri e in grado di fornire elevate prestazioni, semplificando le procedure pur mantenendo rigore nello scopo.

 

Le azioni da compiere:

Il MDCG ha fornito soluzioni di supporto al sistema al fine di garantire l’applicazione delle nuove regole del regolamento in maniera flessibile, invitando gli Organismi notificati a concentrare le loro risorse sulle certificazioni ai sensi dei Regolamento e promuovendo la preparazione di un atto delegato della Commissione, che preveda una rivalutazione completa degli Organismi notificati dopo cinque anni dalla designazione anziché dopo tre anni come previsto attualmente. Il documento si rivolge anche ai fabbricanti, invitandoli a compiere ogni sforzo per incentivare la transizione delle certificazioni al nuovo regime normativo. Con questo stesso presupposto, in Italia, attraverso i decreti legislativi 137 e 138, all’articolo 11 sono previste le autorizzazioni in deroga, il Ministero della Salute può, cioè, autorizzare, su richiesta debitamente motivata, l’immissione sul mercato o la messa in servizio, nel territorio nazionale di dispositivi specifici per i quali le procedure di valutazione della conformità del regolamento non sono state espletate o completate, ma il cui impiego è nell’interesse della salute pubblica o della sicurezza o della salute dei pazienti.

 

La situazione in Europa:

Anche gli altri stati membri si stanno muovendo per trovare una soluzione a questa dinamica. La Francia a settembre ha, per esempio, richiesto ufficialmente alla Commissione europea di rinviare la fine del periodo di transizione. Il governo francese ha preso atto dei rischi di interruzione dell’approvvigionamento di dispositivi medici per i pazienti, sia in città sia in ospedale. Sostenendo che rimangono meno di 20 mesi per certificare 20.000 fascicoli, mentre gli organismi notificati ne possono trattare solo 6.500 all’anno, e annunciano un termine di certificazione di 18 mesi. Con il sistema attuale, qualsiasi dossier che non sarà depositato entro il 24 novembre 2022 è quasi certo di non essere disponibile per i pazienti entro il 2024. Ancora più recentemente, il 07 ottobre, il Consiglio federale tedesco ha pubblicato una risoluzione che richiama l’attenzione sull’urgente necessità di intervenire nell’attuazione del Regolamento europeo sui dispositivi medici. Al fine di continuare a garantire la cura dei pazienti, il Consiglio federale chiede soluzioni immediate per i prodotti di nicchia rilevanti per la cura e facilitazioni tempestive per i legacy devices.

 

Un obiettivo ambizioso e oneroso:

La pubblicazione e la successiva applicazione del Regolamento dei dispositivi medici, a maggio del 2021, ha definito una sorta di rivoluzione all’interno del mondo medicale, in quanto le novità introdotte rispetto alla precedente normativa (Direttiva 93/42) hanno rappresentato e in parte continuano a rappresentare criticità importanti. Gli sforzi impiegati da parte di tutte le organizzazioni coinvolte permetteranno però di ottenere 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.

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19 Jul

Posted at 09:52h in Medical

The label is one of the fundamental parts of the cosmetic product. It is the element that allows the consumer to know what is inside the product, what precautions to take for its use and how long the product can be used safely.

The information to be reported on the label is listed in Article 19 of Regulation (EC) 1223/2009.

This information must be reported on the container and packaging of the product in indelible, easily legible and visible characters. The language of the information shall be determined by the law of the Member States in which the product is made available to the end user.

Information required on the label

– name or registered name and the address of the responsible person.

If several names (e.g. name of the actual manufacturer of the product and name of the responsible person) or addresses are reported on the label, the one where the responsible person makes readily available the product information file shall be highlighted. Usually, to highlight it, it is reported in bold or underlined name to distinguish it from the others. In the case of an imported product, the country of origin must also be present.

– nominal content at the time of packaging.

The content value must be reported by weight or volume (e.g. 5 ml or 5 g).

– date of minimum durability.

It is the date until which the cosmetic product, stored in suitable conditions, will continue to perform its initial function and will remain safe for human health.

The date of minimum duration is shown next to the special symbol in point 3 of Annex VII or by the words: “best used before the end of”.

It is not necessary to report the date for products with a minimum duration of more than 30 months, but in those products shall be r

eported the Period After Opening (PAO), i.e. the period of time (expressed in months or years) after opening in which the product is still considered safe for human health. The PAO is shown together with the symbol in point 2 of Annex VII. The PAO is not necessary for disposable products or products that do not come into contact with the external environment.

– special precautions for use.

Those indicated in Annexes III and IV, any precautions for professional use and those indicated by the safety assessor within the PIF must necessarily be reported

– batch number.

or in any case a reference that allows to identify the product.

– function of the cosmetic product

unless it is clear from its presentation.

– list of ingredients.

The ingredients must be reported in descending order of weight at the time of incorporation into the finished product. Ingredients with a concentration of less than 1% can be listed in no particular order. The ingredients must be reported according to INCI nomenclature, except for the aromatic and odorant compounds that can be reported with the names “parfum” or “aroma” and the colouring compounds that must be reported with their Color Index number. For decorative cosmetic products marketed in several colour shades, all colorants other than colorants intended to colour the hair used in the range may be listed, provided that the words ‘may contain’ or the symbol “+/-” are added. Nanomaterials must be accompanied by the word “nano” in brackets.

What to do if a label cannot be applied to the product

If for practical reasons it is not possible label the list of ingredients and the special precautions for use, the information shall be mentioned on an enclosed or attached leaflet, label, tape, tag or card. The consumer must be referred to these indications applying the symbol in point 1 of Annex VII on the label

In the case of soap, bath balls and other small products where it is impossible for practical reasons for the information about list of ingredients to appear on a label, tag, tape or card or in an enclosed leaflet, this information shall appear on a notice in immediate proximity to the container in which the cosmetic product is exposed for sale.

–  CLP and cosmetic label

Regulation (EC) 1272/2008 does not apply to cosmetic products, therefore hazard pictograms must not be applied on the label of cosmetic products. Sprays with propellant are an exception, as the propellant is subject to the aerosol directive (75/324/EEC). Therefore, on this type of products, the pictogram indicating flammability and other symbols may be requested.

 

In conclusion.

As cited above, label is one of the fundamental parts of the cosmetic product, within PIF. The label allows the consumer to use the product in a conscious way and avoid inappropriate and dangerous uses. Like every request of the Regulation 1223/2009, is responsibility of the responsible person to ensure that all information is correctly reported on the label.

 

Form more informations:

Regulation (EC) 1223/2009:

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32009R1223&from=it

Council Directive (75/324/EEC) :

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:31975L0324&from=IT

Ministero della Salute:

https://www.salute.gov.it/portale/temi/p2_6.jsp?area=cosmetici&id=146&menu=presen#:~:text=L’etichetta%20rappresenta%20il%20mezzo,livello%20di%20informazione%20circa%20le

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28 Jun

Posted at 08:37h in Chemical

ECHA’s Biocidal Products Committee (BPC) met on 8-9 and 14-16 June 2022 and discussed a great number of opinions. These concern five opinions on active substances, ten on requests from the European Commission and nine opinions on Union authorisation.

The committee stands behind the approval of the active substance formic acid for product-types 2, 3, 4, 5 and for use in preservatives for products throughout storage (product-type 6). The opinions will be available on the BPC’s web page in the near future.

The opinions regarding the requests from the European Commission include those on availability and suitability of alternatives to hexaflumuron and on endocrine disrupting properties of formaldehyde releasers.

Finally, the committee supported the following positive opinions on Union authorisations:

  • active chlorine released from chlorineused in disinfectants and algaecides not meant for direct use on people or animals (product-type 2) and for disinfection of drinking water for humans and animals (product-type 5);
  • calcium dihydroxide/calcium hydroxide/caustic lime/hydrated lime/slaked limefor product type 2, and for use in disinfectants, disinfecting soaps, oral or corporal hygiene products or with anti-microbial function (product-type 3);
  • calcium oxide/lime/burnt lime/quicklimefor product-types 2 and 3;
  • peracetic acidfor product-types 2, 3 and for use in disinfecting equipment, containers, consumption utensils, surfaces or pipework associated with the production, transport, storage or consumption of food or feed (including drinking water) for humans and animals (product-type 4);
  • hydrogen peroxidefor product-types 2 and 4;
  • L-(+)-lactic acidfor product-types 3 and 4;
  • L-(+)-lactic acidfor product-types 2, 3 and 4; and
  • 3-iodo-2-propynylbutylcarbamate (IPBC) used in preservation of wood, from and including the saw-mill stage, or wood products by the control of wood-destroying or wood-disfiguring organisms, including insects (product-type 8).

The committee does not stand behind a Union authorisation for hydrogen peroxide for toilet bowl disinfection in professional environments, such as hospitals (product-type 2). The BPC decided that, among other things, the measures that had to be taken to prevent or mitigate exposure throughout use would not be practical nor feasible. It was also said that some co-formulants of the product lead to unacceptable environmental risks.

One Union authorisation opinion concerning chlorocresol was postponed and will be adopted via written procedure.

The European Commission together with EU Member States will make the final decision on approval of active substances and on Union authorisation of biocidal products.

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21 Jun

Posted at 08:30h in Medical

Cosmetic packaging

Packaging material means the container (or primary packaging) that is in direct contact with the formulation.

Within the Regulation (EC) 1223/2009, article 10 says: ” In order to demonstrate that a cosmetic product complies with Article 3, the responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up in accordance with Annex I. ”

In Annex I, section 4, requires reporting “Impurities, traces, information on packaging material” within the safety assessment.

Requests for information on packaging is more detailed in the Commission Implementing Decision 2013/674/EU, where it is indicated that the relevant characteristics of the packaging material in direct contact with the final product are important for the safety of the product and that the reference to Regulation (EC) 1935/2004 may be useful.

Therefore, packaging of cosmetic product must be safe for consumer like the product itself.

 

Effects of packaging on product safety

The combination of packaging material, cosmetic product formulation and contact with the environment

external effects could affect the safety of the finished product, due to the following factors:

a) interaction between the product and the packaging material;

b) barrier properties of the packaging material;

c) migration of the substance from / to the packaging material.

Therefore, when evaluating the packaging, the evaluator must take into account the possible interactions between the components of the packaging and the finished product, the effectiveness of the packaging to isolate the product from the external environment (this also affects the duration of the product after opening) and the substances that can migrate from the packaging to the product and therefore come into contact with the final consumer.

 

What information is needed for packaging evaluation

As there is no specific regulation for cosmetic packaging, the European Commission recommends referring to Reg. 1935/2004 regarding materials and objects intended to come into contact with food.

This indication is taken up by Cosmetic Europe within its guidelines, where it suggests the approach to be adopted in the evaluation of packaging whether it follows the food regulation or not.

 

Packaging in compliance with food regulation

in the majority of cases, if the packaging is safe for a specific type of food, it should also be suitable for cosmetics that have similar physical chemical properties as this food.

If compliance has been based on migration into food/food simulants, the cosmetics assessor needs to decide whether the food/simulants and test conditions/assumptions are applicable to the cosmetics formulation.

Obviously, the evaluator will also have to take into account Annexes II and III of the cosmetic regulation (prohibited and restricted substances).

 

Packaging not in compliance with food regulation

A Cosmetic packaging material might not be food contact compliant because of the presence of a substance that is not authorised for food contact materials or used outside of restrictions set for such use. Non-compliance could also be linked to the material not having been manufactured according to GMP Regulation (EC) N°2023/2006. Such packaging may still be perfectly safe for use in a cosmetic application after the performance of the safety assessment. References to other standards like e.g. pharmaceutical standards or food and feed additives might be helpful in generating useful support information.

 

Sources:

 

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24 May

Posted at 09:25h in Medical

Introduction:

In May the MDCG Guideline 2022 – 5 “Guidance on Borderline between medical devices and medicinal products under MDR 2017/745” was published, at the conclusion of a long comparison within the Community.

Borderline products are those products that by their nature are not immediately traceable to a particular sector, for which it is therefore difficult to define what is the reference legislation to be applied.

The demarcation between Regulation (EU) 2017/745 on medical devices (MDR) on the one hand and Directive 2001/83/EC on medicinal products (MPD) for human use on the other is crucial for the implementation of these legislative acts and for their correct interpretation and application.

 

General aspects:

As a general rule, a product is regulated either by the MDR or by the MPD but not both. The conformity assessment procedure or the marketing authorisation procedure to be followed prior to placing a given product on the market will therefore be governed either by the MDR or by the MPD.  The procedures of both regulatory regimes do not apply cumulatively. However, for products that have properties of both medicinal products and medical devices (e.g. medical devices incorporating as an integral part, a substance which, if used separately, would be considered to be a medicinal product), some cross-references are made within one regime to specific provisions of the other regime.

The wording of Article 2(2) of the MPD shows that it only applies if, after a case-by-case assessment, taking in consideration all the characteristics of a product, the product in question may fall within the definition of both, medical device and medicinal product. In such a case, the provisions of the MPD applies5. The MDR and the MPD may not be applied cumulatively.

The aim of this guideline is to support the uniform application of the Regulation throughout the European Union.

The document starts with the general discussion of the borderline between medical devices and medicinal products, including relevant definitions and examples. Separate chapters are dedicated to herbal products, substance-based devices and medical device and medicinal product combinations.

According to Article 1(6)(b) of the MDR, in deciding whether a product falls under the MDR or the MPD particular account shall be taken of the principal mode of action of the product. The nature of the principal mode of action i.e. whether it is pharmacological, immunological or metabolic or other is generally the same irrespective of the quantity.

According to Article 2(1) MDR a medical device does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but may be assisted in its function by such means. The concept that a medical device may be assisted in achieving its principal intended action by pharmacological, immunological or metabolic means should be understood as covering those cases when the medical device incorporates, as an integral part, a substance which, if used separately, would be considered to be a medicinal product, and that has an action ancillary to that of the device.

Typically, the medical device’s principal intended action is achieved by physical means (including mechanical action, physical barrier such as a film, lubrication, heat transfer, radiation, ultrasound, replacement of or support to organs or body functions). Furthermore, hydration or dehydration and pH modification may also be means by which a medical device achieves its principal intended action.

The determination of the nature of the substance, i.e. whether it is “considered to be a medicinal product” is independent of the intention of the manufacturer, of the quantity of the substance in the device and of the method or route of administration.

 

Conclusion:

The document may be revised in the light of the update of technical-scientific knowledge and in the light of the results of discussions within the Borderline and Classification medical devices expert group (B&C) of the Medical Device Coordination Group.

 

For more information: https://ec.europa.eu/health/latest-updates/mdcg-2022-5-guidance-borderline-between-medical-devices-and-medicinal-products-under-regulation-eu-2022-04-26_en

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23 May

Posted at 08:30h in Company News

Webinar – La valutazione biologica di un dispositivo medico

Martedì 31.05.2022

Ore 10:00 – 11:00

Programma:

  • La valutazione biologica come parte del processo di gestione del rischio
  • Perché eseguire la valutazione della sicurezza biologica
  • Come dimostrare la conformità ai RGSP
  • La caratterizzazione chimica come requisito necessario per una corretta valutazione biologica
  • Il “Biological Evaluation Plan” (BEP)

 

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