MDCG 2022-4 published: Notified Body surveillance of MDR legacy devices

2022-02

Article 120(2) and 120(3) of the Medical Device Regulation (EU) 2017/745 (MDR) state that devices which are covered by valid certificates issued by a notified body under the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) or the Medical Devices Directive 93/42/EEC (MDD) may be placed on the market or put into service after the date of application of the MDR (26 May 2021) and no later than 26 May 2024 under certain conditions.

The abovementioned conditions require that the notified body that issued the certificate under the MDD or the AIMDD continues carrying out appropriate surveillance with respect to all applicable requirements relating to the devices it has certified. Therefore, it is important for manufacturers, notified bodies and national authorities to get clarity on activities to be part of the appropriate surveillance referred to in Article 120(3) of the MDR.

To appropriately address application of transitional provisions to devices covered by certificates according to MDD or the AIMDD, this guidance, drafted in line with MDCG 2021-25 on application of MDR requirements to ‘legacy devices’, should be read in conjunction with guidance MDCG 2020-3 on significant changes.

The document discusses following topics:

  • Requirements in respect to the manufacturer’s quality management system and related obligations
  • Surveillance according to Article 120(3) MDR
  • Possible scenarios for the surveillance according to Article 120(3) MDR

The document can be downloaded from our library

Source: European Commission

MDCG 2022-2 Guidance on clinical evidence IVDs published

2022-01

On January 27 the MDCG published 2022-2 Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs).

This guidance describes the approach by which collection, generation and documentation of supporting data for an IVD may be conducted prior to the placing on the market or putting into service. As the performance evaluation will be updated throughout the life cycle of an IVD, this document also addresses principles related to post-market surveillance, such as post-market performance follow-up.

The target audience of this document is IVD manufacturers, investigators and study sponsors. This document is also intended to inform regulators, notified bodies and other stakeholders when considering clinical evidence provided by manufacturers.

The document can be downloaded in our library

Source: European Commission

European Commission Press release on IVDR transitional periods

2021-12

On December 20, 2021, the European Commission issued a Press release on the positive adoption by the European Parliament and the Council of the proposal of October 2021, for a progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation of 2017.

The amending Regulation does not change any requirements of the original IVDR. It only changes the dates of application of some of these requirements for certain medical devices.

For higher risk devices, such as HIV or hepatitis tests (class D), the new requirements will apply as from May 2025. For devices of the lower risk class C, such as certain influenza tests, the date of application is extended until May 2026, whilst for lower risk class devices (class B and A sterile), the application starts in May 2027.

Moreover, the application of certain requirements for devices manufactured and used in the same health institution (so-called ‘in-house devices’) is delayed by two years until May 2024. If, however, the health institutions prove the unavailability of an equivalent device on the market, the transitional periods will end in May 2028.

The document can be downloaded in our library

Source: European Commission

New Regulation about electronic user instructions of medical devices

2021-12

A new Regulation (2021/2226/EU) about electronic instructions for use (eIFU) of medical devices has been published. This Regulation outlines the circumstances in which the user instructions can be presented in an electronic format instead of paper format.

According to this Regulation, instructions for use may be provided as eIFU for the following types of devices, covered by Regulation MDR (EU) 2017/745 and intended for professional use only (e.g. use by other persons is not reasonably foreseeable):

  • Implantable, and active implantable medical devices and associated accessories;
  • Fixed installed medical devices and associated accessories;
  • Medical devices and associated accessories with an integrated system for displaying instructions for use.

For software covered by MDR, manufacturers may provide eIFU directly via the software itself.

Requirements to be met by the manufacturer to provide eIfU are further described in the Regulation.

The document can be downloaded from our library

Source: EUR-Lex

MedTech Europe issues 2nd edition of the Clinical Evidence Requirements for CE certification under the IVDR

2021-12

The “Clinical Evidence Requirements for CE certification under the In vitro Diagnostic Regulation in the European Union” (First Edition May 2020, Second Edition November 2021) is a collection of questions and answers designed to help manufacturers navigate their performance evaluation obligations under the new IVD Regulation 2017/746.

The document can be downloaded in our library

Source: MedTech Europe

MedTech Europe publishes ‘Use of Symbols to Indicate Compliance with the MDR’ v3.0

2021-12

MedTech Europe annouces the version 3.0 of the guidance on symbols on labels to indicate MDR (Medical Device Regulation EU 2017/745) compliance. The guidance now aligns with the published ISO 15223-1 (2021)1.

MedTech Europe has been closely engaged in the work on symbols at ISO over the past few years, which led to the publication of the first version of this guidance in May 2019 and a subsequent version in December 2019.

The document can be downloaded in our library

Source: MedTech Europe

Press release: European Commission proposes a progressive roll-out of the new IVDR

2021-10

On October 14, 2021, the European Commission published a press release with a proposal for a progressive roll-out of the new IVDR.

The proposal does not change any requirements of the In Vitro Diagnostic (IVD) Regulation in substance but only changes the transitional provisions to allow the Regulation’s progressive rollout. The length of the proposed transition periods depends on the type of device: higher risk devices such as HIV or hepatitis tests (class D) and certain influenza tests (class C), have a transition period until May 2025 and 2026, whilst lower risk ones such as class B and A sterile devices, have a transition period until May 2027.

The proposal and the press release can be downloaded in our library

Source: European Commission