MDR Update: Notified Body designations and first MDR CE Certificate

MDR Update: Notified Body designations and first MDR CE Certificate

Until this day, the European Commission announced 4 designated Notified Bodies to certify devices under the Medical Device Regulation (EU 2017/745):

1)      BSI Assurance UK Ltd

2)      DEKRA Certification GmbH

3)      IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.

4)      TÜV SÜD Product Service GmbH Zertifizierstellen

BSI UK already informed the medical device community it certified the first device under the new Regulation (EU 2017/745) and issued the related CE Certificate assessing conformity with the new legal requirements.

Who will cease their operations due to the MDR?

UK Lloyd's Register Quality Assurance (LRQA)informed their clients on the cessation of its activities as Notified Body under the new regulatory framework, in addition to the Swiss QS Zürich AG and Spanish Agency of Medicines and Medical Products (AEMPS).

On the positive note, the European Commission plans to announce the designation of as many Notified Body as possible before the MDR becomes applicable in May 2020 - in view of the 52 applications already received and 33 joint assessments carried out.


Ajda Mihelcic

Deputy Manager of Publishing department

September 6, 2019


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