News about GMP/cGMP

21.08.2019

Italian IMQ Istituto Named Fourth Notified Body under MDR

As announced by the European Commission on 20 August 2019, the IMQ Istituto located in Milan, Italy, has been notified as the fourth Notified Body under the new European MDR to come in 2020. This is still too little, according to the opinion within the medical device industry.

Calls for a postponement of the MDR’s entry into force are getting louder. This is justified with

  • the number of so far Notified Bodies which is insufficient
  • the number of Notified Bodies that do not wish to apply for MDR certification in the future, e.g. Lloyd's Register Quality Assurance, UL International and the Swiss QS Zurich
  • the current prospect of a disorderly Brexit.

The implementation status of the MDR can be tracked in the "Implementation Rolling Plan": Currently 33 of 52 applications received for certification as a Notified Body have been subject to joint assessments and 4 of these have been certified (BSI UK, TÜV SÜD, Dekra Certification, IMQ) as of today.


Source:

MDR and IVDR implementing measures rolling plan

EC Notified Bodies Nando



Comments

No comment has yet been written about this news


Write your comment about this news