New regulatory guidance documents on MDR (MDCG 2020-1 to -4)

 

Dear Sir or Madam,

we would like to inform you that new MDCG documents were published at the beginning of 2020, which you can view or download below:

 

MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software

MDCG 2020-2 Class I Transitional provisions under Article 120 (3 and 4) – (MDR)

MDCG 2020-3 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD

MDCG 2020-4 Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions

 

Update Transition MDD to MDR

 

Due to inquiries, we would like to make the mailing more precise:

the EU Medical Device Regulation (MDR) was originally intended to come into force in a few weeks. We would like to inform you that (subject to the approval of the EU member states) that the EU Parliament has accepted the proposal provided by the EU Commission to delay MDR by one year. May 26th 2021 is going to be the new date of full MDR application.

For this reason, we can accept applications for new products or product changes under Medical Device Directive (MDD) from existing customers, which are submitted to us by 30.08.2020 together with the complete documentation.

Please use exclusively our contact medical@tuev-nord.de for your applications.

 

Yours sincerely,
Your Team
Medical Device International
TUV NORD CERT


 

TÜV NORD CERT GmbH

Langemarckstr. 20
45141 Essen

Tel.: 0800 2457-457
(kostenlose Service-Hotline)

info.tncert@tuev-nord.de
www.tuev-nord-cert.de

 

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