Medical device CE marking

25th NB under the MDR designated: SGS Belgium NV

2021-11

MDR:

The 25th Notified Body under the MDR was designated and included in the NANDO database: SGS Belgium NV (NB #1639).

Previously designated in 2021: CERTIQUALITY S.r.l. (NB #0546), TUV Rheinland Italia SRL (NB# 1936), Eurofins Product Testing Italy S.r.l. (NB #0477), Kiwa Cermet Italia S.P.A. (NB #0476), Eurofins Expert Services Oy (NB# 0537) in Finland, Instituto Superiore di Sanita’ (ISS) (NB# 0373) in Italy and SGS FIMKO OY (NB# 0598 / ex-0403) in Finland.

Source: NANDO database

IVDR:

On August 19, the 6th Notified Body under the IVDR was designated and included in the NANDO database: GMED SAS (NB #0459) in France.

The other 5 are:
BSI Group The Netherlands B.V. (NB# 2797)
DEKRA Certification B.V. (NB# 0344)
DEKRA Certification GmbH (NB# 0124)
TÜV Rheinland LGA Products GmbH (NB# 0197)
TÜV SÜD Product Service GmbH Zertifizierstellen (NB# 0123)

Source: NANDO database

Updated MDCG Joint Implementation Plan on IVDR

2021-10

On October 29, 2021, the MDCG published  an updated Joint Implementation Plan on the IVDR. This Joint Implementation Plan is the result of review by the MDCG including the relevant sub-groups, with input from stakeholders. It has been endorsed in principle in the MDCG meeting of 28 May 2021.

In addition to setting the priorities, the plan will serve as a living document to monitor their implementation. The status and timelines of the items will be updated to reflect the progress of the work.

The document can be downloaded in our library

Source: European Commission

MDCG 2021-25 report issued on transitional provisions

2021-10

The MDCG ad hoc task-force on transitional provisions (‘legacy devices’ and devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC) has issued the MDCG 2021-25 report, which has been endorsed as an MDCG guidance.

The document can be downloaded in our library

Source: European Commission

 

MDCG 2021-24 Guidance on classification of medical devices

2021-10

On October 4 the MDCG published 2021-24: Guidance on classification of medical devices.

The document is divided into 4 chapters:
– Purpose of medical device classification
– Practical relevance of classification
– How to carry out classification
– Explanations of individual rules.

The document can be downloaded in our library

Source: European Commission

Medtech Europe Survey – IVD manufacturer

2021-09

MedTech Europe, the European trade association for the medical technology industry including diagnostics, medical devices and digital health, ran a survey in July 2021 to gather data from IVD manufacturers on the state of the IVD market today and how they are expected to transition to the IVD Regulation within ten months from the survey date. The survey, which represents an estimated 90% market revenue coverage, was commissioned by the Competent Authorities for Medical Devices (CAMD) Task Force on Certification Capacity Monitoring.

Many IVDs are not expected to receive certification by the deadline of 26 May 2022 under the IVD Regulation. The highest proportionate loss of IVDs will come from small and medium sized manufacturers, many of whom make niche products in smaller volumes and who may be more prone to run out of business. From the survey data, an estimated best-case scenario where 61% of today’s IVDs will be certified by 26 May 2022 and a worst-case scenario where only 24% will.

The full survey report may be read here.

CEN and CENELEC announced their new website

2021-09

On September 1st, 2021, the CEN (European Committee for Standardization) and CENELEC (European Committee for Electrotechnical Standardization) announced their new website – www.cencenelec.eu.

The website aims to offer an enhanced user experience: it features a refreshed look, improved navigation and a handful of features which will make the overall experience more impactful on either desktop, mobile or tablet.

Among the relevant features of the website, CEN and CENELEC have worked on centralising and providing targeted information to stakeholders and the general public on sectors, news, and events. Furthermore, a dedicated expert area has been introduced, providing a central access to all CEN and CENELEC support tools and applications.