Medical device CE marking

New NB under the IVDR and new NB under the MDR designated

2021-09

MDR:

On September 2nd, 2021, the 23rd Notified Body under the MDR was designated and included in the NANDO database: TUV Rheinland Italia SRL (NB# 1936).

Previously designated in 2021: 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

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.

 

MDCG 2021-22 Clarification on first certification – IVDR

2021-08

On August 18, the European Commission published MDCG 2021-22: Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746.

The document can be downloaded in our library

Source: European Commission

New forms for Notified Bodies in the scope of the MDR and the IVDR

2021-07

On July 15, the European Commission published 4 new forms for Notified Bodies in the scope of the MDR and the IVDR:

  • MDCG 2021-15: Application form to be submitted by a conformity assessment body when applying for designation as notified body under Regulation (EU) 2017/745 on medical devices (MDR)
  • MDCG 2021-16: Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation (IVDR)
  • MDCG 2021-17: Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR)
  • MDCG 2021-18: Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR)

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

Source: European Commission

MDCG 2021-13 Q&A on Actor ID

2021-06

On June 23 the European Commission published MDCG 2021-13: Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR.

The document can be downloaded in our library

Source: European Commission

Update (Rev. 1) on July 12, 2021

MDCG 2021-12 FAQ on EMDN

2021-06

On June 4, the MDCG issued MDCG 2021-12 on FAQ on the European Medical Device Nomenclature (EMDN).

Six questions answered regarding EMDN:
1. What is the European Medical Device Nomenclature (EMDN)?
2. How was the EMDN created?
3. What are the key principles of EMDN?
4. How do I gain access to the EMDN?
5. How is the EMDN structured?
6. Which level of the EMDN should I use to assign a term to my device?

The document can be downloaded in our library

The same document can also be found in our library in a different format / layout, published by the European Commission on June 15, 2021.

Source: European Commission