Medical

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.

Get the original document at the link below.

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

MDCG 2021-1
Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional

 

There are many questions and doubts concerning the European Database for Medical Devices, EUDAMED, and how to be compliant to the Medical Devices Regulation (EU) 2017/745 (MDR) and the In-Vitro Diagnostic Medical Devices Regulations (EU) 2017/746 (IVDR) in the absence of the full functionality of EUDAMED.

Even if the full application of the MDR has been postponed to May 26th, 2021 due to the corona virus pandemic, EUDAMED is expected to be fully operational by May 2022, leaving a one-year gap between the two dates.

The Medical Device Coordination Group has released a new guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional juts a few days ago.

This document provides guidance on the application of certain MDR provisions during the absence of EUDAMED to enable Member States and other relevant parties to meet their obligations under the MDR effectively. It is important to remember that all MDR requirements will apply as relevant, this means the obligation of generating certain information (for example: UDI, Summary of Safety and Performance (SSCP), Periodic safety update report (PSUR)) even if they cannot jet be uploaded to EUDAMED.

The guidance provides a table displaying the articles of the MDR concerning the use of EUDAMED and the suggested alternative solutions to submit and/or exchange information.

See also our other post: Management of Legacy Devices in Eudamed

For the whole document please click link below.

Official document of the European Union on how to identify legacy devices in Eudamed

 

What are Legacy Devices?

Legacy Devices are Medical Devices, Active Implantable MDs and In Vitro Diagnostic MDs which are covered by a valid certificate issued in accordance with the respective MDDs (Directive 93/42/EEC, Directive 90/385/EEC, Directive 98/79/EC) and that continue to be placed on the market after the date of application of the MDR/IVDR (Regulation (EU) 2017/745 (MDR)/Regulation 2017/746).

Registration in Eudamed:

The registration in Eudamed of Legacy Devices is possible, but mandatory in case of a serious incident or if a field safety corrective action applies, which requires registration as soon as possible and at least before a follow up or final vigilance report is submitted.

Furthermore, if 18 months after the date of application of the MDR or IVDR (or 24 months after the date of publication of the notice referred to in Article 34(3) if EUDAMED is not fully functional before the date of application of the MDR), the equivalent device is not made compliant and registered as a MDR or IVDR device, the Legacy Device must be registered in EUDAMED within this time period.

Devices compliant to the Directives with the risk class I that are not sterile and/or with a measuring function cannot be considered as Legacy Devices because they do not require a certificate issued by a Notified Body. Such Devices must be registered only as Regulation Devices in EUDAMED within the 18 months after the date of application (or 24 months after the date of publication if EUDAMED is not fully functional).

 

Assignment of a Basic UDI-DI and a UDI-DI

To keep the same structure and identification elements for all Devices registered in EUDAMED, an identification element EUDAMED DI (equivalent of Basic UDI-DI) will be required, and a EUDAMED ID (if no UDI-DI has been assigned) will be generated from the EUDAMED DI.

The Basic UDI-DI will never be applicable and never be assigned to a Legacy Device, only EUDAMED DI, the UDI-DI can be used to identify a Legacy Device in EUDAMED.

Only one device identifier will be assigned to a Legacy Device, either a UDI-DI (where the EUDAMED DI is automatically generated) or a EUDAMED DI (where the EUDAMED ID is automatically generated).

The official document contains flowcharts and examples to better understand how to register and identify your devices in EUDAMED.

Get it here: See link below

It is finally here: the long-anticipated ISO 10993-23 was published January 20th, 2021.

 

The manufacturer is obliged to evaluate each device for potential adverse effects prior to marketing. Some materials used for medical devices have demonstrated skin or mucosal irritation potential. Other materials and their chemical components have not been tested and could therefore induce adverse effects when in contact with human tissue.

The irritation potential of a medical device or its components can be predicted either in vivo or in vitro, if qualified for use with medical devices.

This new document reinforces the animal welfare aspects already mentioned in ISO 10993-2, emphasizing the 3R’s (replacement, reduction, and refinement of animal studies) for the biological evaluation of medical devices. Meaning that in vitro tests have preference over in vivo tests when appropriately validated and providing equally relevant information.

Major shoutout to RhE models: For skin irritation testing of neat chemicals in vitro tests were developed using reconstructed human epidermis. The method was adapted for detection of irritant chemicals in medical device extracts. These RhE models can also detect the presence of irritant chemicals extracted from polymeric materials [polyvinylchloride (PVC) and silicone] commonly used in the manufacture of medical devices. This method was found to be equally sensitive when compared to the human patch testing and intracutaneous rabbit test.

Given the encouraging results from the developed and validated RhE models it is recommended to explore the use of other alternative in vitro models to assess the irritation potential for mucosal or eye epithelial applications.

 

Preview of the official document:

This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials, or their extracts according to ISO 10993-1 and ISO 10993-2.

This document includes:

  • pre-test considerations for irritation, including in silicoand in vitro methods for dermal exposure;
  • details of in vitroand in vivo irritation test procedures;
  • key factors for the interpretation of the results

Get the English version at the link below

VISITA IL SITO: 74151.html