Medical device CE marking

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

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

2021-02

The MDCG issued guidance 2021-1: this 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

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

New IVD symbols for compliance with the IVDR

2020-10

By 26 May 2022, IVD devices will transition to the new IVD Regulation EU 2017/746. This regulation will require devices intended for self-testing, devices intended for near-patient testing and certain rapid tests (not for self-testing and not for near patient testing) to state these facts on their labels.

The use of symbols on the label is an effective way of compliance and it is permitted by the IVDR. By including these symbols proposed by MedTech Europe, the intended user of your device will be clear. It will also remove the necessity to translate that indication into all EU languages.

The document can be downloaded in our library

Source: MedTech Europe

Common Specification for reprocessing of single use devices

2020-08

The European Commission has published the first common specifications under the MDR. It concerns reprocessing of single use devices.

Under MDR, single-use devices may be reprocessed where permitted by national law. Member states may also determine what rules they will apply to single-use devices reprocessed and used within a health institution, so long as the reprocessing is performed in accordance with the common specifications laid out in the regulation.

To ensure the quality of the reprocessing activities, CS concerning risk management should include minimum requirements for staff, premises and equipment.

Source: https://eur-lex.europa.eu/eli/reg_impl/2020/1207/oj

Consolidated MDR now available (2020-04-24)

2020-05

The consolidated MDR is now available on the European Commission website.

 

Amended by:

Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020

 

Corrected by:

Corrigendum, OJ L 117, 3.5.2019, p.  9 (2017/745)

Corrigendum, OJ L 334, 27.12.2019, p.  165 (2017/745)

 

The consolidated MDR can be downloaded in our library

Source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20200424