Medical device CE marking

MDCG 2021-1 Guidance on administrative practices until EUDAMED is fully functional

2021-05

The MDCG issued guidance 2021-1 in February 2021 and the document was updated with Rev 1. on May 4, 2021. The document provides guidance to Member States and other relevant parties on the application of certain MDR provisions during the absence of EUDAMED. To that end, this guidance intends to describe harmonised administrative practices and alternative technical solutions for the exchange of information until EUDAMED becomes fully functional.

The document can be downloaded in our library

Source: European Commission

European Commission publishes Factsheet for Class I Medical Devices

2021-04

On April 28, the European Commission published a useful three-page Factsheet for 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 (MDR). For further information, consult MDCG 2019-15 rev.1.

The document can be downloaded in our library

Source: European Commission

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

2021-04

On April 22, the MDCG published 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.

Eurofins Expert Services Oy 20th NB under the MDR

2021-04

MDR:

On April 7, 2021, the 20th Notified Body has been designated under the MD Regulation and included in the European Commission NANDO database: Eurofins Expert Services Oy (NB# 0537) in Finland.

The 19th Notified Body was designated on February 16, 2021: Instituto Superiore di Sanita’ (ISS) (NB# 0373) in Italy and the 18th Notified Body on January 9, 2021: SGS FIMKO OY (NB# 0598 / ex-0403), Finland.

This follows the removal of BSI UK (NB# 0086) from NANDO on 1 January 2021 as a direct consequence of the UK leaving the European Union and the designation of UDEM Adriatic d.o.o. (NB# 2696) on December 15, 2020.

Source: NANDO database

IVDR:

The current status of NBs under the IVDR is still 4, after removal of BSI UK as per January 1st, 2021.

Source: NANDO database

COVID-19 Q&A

2021-02

The European Commission issued a Q&A on in vitro diagnostic medical device conformity
assessment and performance in the context of COVID-19.

The document can be found in our library.

Source: European Commission

EC guidance on legacy devices in EUDAMED

2021-02

The European Commission has published a document explaining how and when legacy devices will be identified in the new Eudamed medical device database. Legacy devices are products that have been CE marked in the context of the current medical device directives but not under the new Medical Device Regulation, nor the IVD Regulation.

The Management of Legacy Devices is a technical document, the majority of which consists of flowcharts and other tables, which explains how the different Unique Device Identifiers (UDIs) will be generated/assigned for legacy devices as part of registration.

The document can be downloaded in our library.

Source: European Commission