Medical device CE marking

IMDRF publishes guiding principles to support medical device health equity

2024-02

Guiding principles have been developed for use by the IMDRF to advance health equity discussions for underrepresented populations in the development, evaluation and regulation of medical devices. This document is intended to assist IMDRF working groups in considering health equity principles, where relevant, in the development of IMDRF technical documents. These principles should be considered throughout the total product lifecycle.

Each working group will determine how best to use this document in their discussions and deliverables.

The document can be downloaded in our library

Source: IMDRF

MDCG 2024-2 published on Procedures for the updates of the European Medical Device Nomenclature

2024-02

The European Medical Device Nomenclature (EMDN), as established by Article 26 of the MDR and Article 23 of the IVDR, will be annually reviewed and updated based on the practical use of the EMDN and feedback from its users.

This document lays out the procedures for the annual revision as well as the procedure for ad-hoc requests requiring an expedited review.

The document can be downloaded in our library.

Source: European Commission

MDCG issues 1 template and 4 guidances on device specific vigilance

2024-01

The MDCG issued 4 device specific guidances on the vigilance system for CE-marked devices:

And also a template:

  • MDCG 2024-1DSVG 00: Device Specific Vigilance Guidance (DSVG) Template

The documents can be downloaded in our library (see links above)

Source: European Commission

EC proposes to extend transition periods for certain IVDs, gradual roll-out of Eudamed and an information obligation in case of interruption of supply

2024-01

In 2017, the EU introduced new rules for medical devices and in vitro diagnostics to ensure a better protection of public health and patient safety.

Despite considerable progress in transitioning to these rules and the additional time given to the sector to implement them, the transition remains slow. In 2023, the Commission took measures to ensure the availability of medical devices. Today, we are proposing to take additional steps:

  • to ensure the availability of in vitro diagnostics by allowing more time for manufacturers to transition to the new rules, subject to certain important conditions.
  • to enhance transparency and protect patient care by speeding up the launch of some parts of the European Database on Medical Devices – EUDAMED
  • to provide healthcare systems with more time to safeguard patient care by obliging manufacturers to notify in case of disruption of supply of certain medical devices and in vitro

The documents can be downloaded in our library: Commission proposal, Press release, Q&A and Factsheet

The Proposal will now be put forward to the European Parliament and Council for adoption.

Source: European Commission

MDR and IVDR language requirements for manufacturers published

2024-01

The Commission and Member States have created MDR and IVDR tables.

These tables aim to help manufacturers of medical devices and in vitro diagnostic medical devices, particularly small and medium-sized ones, understand the language requirements for the information and instructions that accompany a device in a specific country. The tables provide an overview of the language requirements for each Member State.

Graphic User Interface (GUI)
The last column of the tables includes the language requirements about the graphic user interface (GUI) (e.g., apps). There is no specific article foreseen in MDR/IVDR, but some countries have their own national legislation and rules about GUIs.

The documents can be downloaded in our library: MDR / IVDR

Source: European Commission

MDCG 2021-27 Revision 1 published

2023-12

On December 19, 2023, the European Commission published revision 1 of the MDCG 2021-27: on “Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746”.

This document presents questions and answers on requirements related to importers and distributors under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The term ‘devices’ will be understood to include medical devices, accessories for medical devices, products listed in Annex XVI of the MDR, in vitro diagnostic medical devices and accessories for in vitro medical devices.

The revision 1 can be downloaded in our library

Source: European Commission

 

MDCG 2023-5 and MDCG-6 guidances published on Annex XVI products

2023-12

On December 14 2 new guidances were published by the MDCG:

MDCG 2023-5: Guidance on qualification and classification of Annex XVI products – A guide for manufacturers and notified bodies
Products without an intended medical purpose that are listed in the Annex XVI to MDR and that are included in the scope sections of the CS’ annexes are covered also by the MDR. Qualification of a product without an intended medial purpose precedes its classification. Only products that qualify as devices and that are covered by the CS and the MDR should then be classified according to the rules set out in Annex VIII to MDR and in Commission Implementing
Regulation (EU) 2022/2347 on reclassification
. Classification rules set out in Annex VIII to MDR apply to those products. Also Commission Implementing Regulation (EU) 2022/2347 applies for classification purposes of certain active devices without an intended medical purpose.

MDCG 2023-6: Guidance on demonstration of equivalence for Annex XVI products – A guide for manufacturers and notified bodies.
According to Commission Implementing Regulation (EU) 2022/2346 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 on medical devices5, hereinafter referred to as CS, in general it is not possible to demonstrate equivalence between a medical device and a product without an intended medical purpose where all available results of clinical investigations relate to medical devices only. Therefore, clinical investigations should be performed for products without an intended medical
purpose
.

Both guidances can be downloaded in our library (see above links)

Source: European Commission

MDCG 2021-6 MDR – Questions & Answers regarding clinical investigation – Rev.1

2023-12

On December 12, the MDCG published Revision 1 of guidance 2021-6: Regulation (EU) 2017/745 ̶ Questions & Answers regarding clinical investigations, a document that answers many outstanding questions relating to clinical investigations.

The guidance deals with the fundamental issue of what the general differences and improvements related to clinical investigations are under the MDR as compared with the medical device directives and is broken into sections dealing with the following topics: general questions; modifications; timeline considerations; clinical investigation reports; and arrangements for the transitional period.

The document can be downloaded in our library.

Source: European Commission.

2023/2713: Regulation on designating European Union reference laboratories in the field of in vitro diagnostic medical devices

2023-12

On December 6 Regulation 2023/2713 was published in the Official Journal.

When an EU reference laboratory is designated, according to Regulation (EU) 2017/746, class D devices have to undergo a performance verification and batch testing by the EU reference laboratory. To ensure sufficient availability of EU reference laboratory services, the selection board also took into account the collective capacity of the candidate laboratories for performance verification and batch testing.

The document can be downloaded in our library

Source: EUR-Lex

Notice to manufacturers to ensure timely compliance with MDR requirements

2023-11

The European MDCG has issued a Revision 1 of the position paper timely compliance with MDR and IVDR requirements.

Six years have passed since the adoption of MDR and IVDR and the implementation of the regulations is advancing. The Regulations’ transitional provisions have been amended to give manufacturers and notified bodies more time to conduct the necessary conformity assessment procedures and to avert shortages of devices needed for the EU healthcare systems.

The MDCG calls to manufacturers to transition to the Regulations and submit their applications for certification without further delay.

Currently there are 42 MDR and 12 IVDR Notified Bodies accredited: NANDO database

The document can be downloaded in our library

Source: European Commission