Mai 18, 2021
Regulatory

Countdown to MDR

In the lead-up to the application of the MDR on 26 May, the European Commission has recently released a series of documents and information. Furthermore, three new notified bodies have been authorized.

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New Notified Bodies
The NANDO databank has recently listed three new notified bodies designated for MDR:

- Eurofins Expert Services Oy of Finland
- SGS Fimko Oy (Finland)
- Istituto Superiore di Sanità (Italy)

The list now includes 20 notified bodies for MDR and just four for IVDR designation. According to an overview released in March the European Commission has received 53 applications for MDR designation with only 16 for IVDR designation. The low number of notified bodies will likely lead to increasing discussion about the appropriateness of postponing the IVDR date of application.

The UDI Helpdesk is live
The helpdesk aims to provide support to economic operators in the implementation of the obligations and requirements introduced by the new UDI system, which include UDI assignment, labelling and registration of devices. The helpdesk will also provide support as regards the use of the European Medical Devices Nomenclature (EMDN), which the European Commission has made available to the manufacturers and other natural or legal persons required by the MDR and IVDR to use it.

Solutions until EUDAMED is fully functional
The document Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional provides guidance to Member States and other relevant parties on the application of certain MDR provisions during the absence of EUDAMED, which will not be fully functional on the date of application of the MDR. This guidance intends to describe harmonized administrative practices and alternative technical solutions for the exchange of information until EUDAMED becomes fully functional.

Factsheet for Class I - Medical Devices
This factsheet is aimed at manufacturers of Class I medical devices. It covers devices that have already been placed on the market under Directive 93/42/EEC (MDD) and new devices intended to be placed on the market for the first time in accordance with Regulation (EU) 2017/745 of the European Parliament and the Council of 5 April 2017 (MDR).

Basic UDI-DI and changes to UDI-DI
The guidance Revision 4 - Guidance on basic UDI-DI and changes to UDI-DI is intended to provide a clarification on the notion of Basic UDI-DI, its use in relevant documentation and the factors triggering UDI-DI changes.

Clinical investigations -Q&As
The document Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation is intended for sponsors of clinical investigations of medical devices conducted within the scope of the Regulation (EU) 2017/745 (MDR).

Standardisation for medical devices
The document Guidance on standardisation for medical devices aims to provide guidance on different aspects related to standards in the medical devices sector in support of the requirements laid down in the applicable EU legislation, taking into account its specificities.

Source: European Commission