News, opinions and insights about medical device regulations and standards

Notícias, opiniões e insights sobre regulamentos e normas de dispositivos médicos

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Category: In Vitro Diagnostic Medical Device Regulation IVDR

EU – EUDAMED State Of Play : Open Letter From The CAMD Executive Group

28 Nov, 2019 Marcelo Antunes Competent Authorities for Medical Devices - CAMD, European Database on Medical Devices - EUDAMED, In Vitro Diagnostic Medical Device Regulation IVDR, Medical Device Regulation MDR

EU – EUDAMED State Of Play : Open Letter From The CAMD Executive Group

From RAPS – Danish Medicines Agency Ramps Up Capacity in Medical Devices

3 Nov, 2019 Marcelo Antunes Danish Medicines Agency (Lægemiddelstyrelsen), In Vitro Diagnostic Medical Device Regulation IVDR, Medical Device Regulation MDR

Danish Medicines Agency Ramps Up Capacity in Medical Devices

EU – REACH Authorisation Decisions List

29 Oct, 2019 Marcelo Antunes Biological Evaluation, European Commission, In Vitro Diagnostic Medical Device Regulation IVDR, Medical Device Regulation MDR, Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

REACH Authorisation Decisions List

BSI UK notified under the IVDR

26 Oct, 2019 Marcelo Antunes In Vitro Diagnostic Medical Device Regulation IVDR, Notified Body

Second NB under the IVDR notified – BSI UK notified under the IVDR

EU – Ongoing Guidance development within MDCG Subgroups

25 Oct, 2019 Marcelo Antunes Guidance, In Vitro Diagnostic Medical Device Regulation IVDR, MDCG - Medical Devices Coordination Group, Medical Device Regulation MDR

Ongoing Guidance development within MDCG Subgroups

EU – Possible EUDAMED delay

25 Oct, 2019 Marcelo Antunes European Database on Medical Devices - EUDAMED, In Vitro Diagnostic Medical Device Regulation IVDR, Medical Device Regulation MDR

So it seems EUDAMED will be delayed by 2 years. Let’s see if an official announcement is made soon…

EU – EMA revised guidance – Questions & Answers on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746)

22 Oct, 2019 Marcelo Antunes European Medicines Agency - EMA, In Vitro Diagnostic Medical Device Regulation IVDR, Medical Device Regulation MDR

Questions & Answers on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746)

EU – Flyer – Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05)

19 Oct, 2019 Marcelo Antunes Expert Panels, In Vitro Diagnostic Medical Device Regulation IVDR, Medical Device Regulation MDR

Flyer – Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05)

EU – Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR

11 Oct, 2019 Marcelo Antunes In Vitro Diagnostic Medical Device Regulation IVDR, Medical Device Regulation MDR, Software as Medical Device - SaMD

Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR

EU – First IVDR designated Notified Body – DEKRA Certification GmbH

10 Oct, 2019 Marcelo Antunes In Vitro Diagnostic Medical Device Regulation IVDR, Notified Body

Regulation (EU) 2017/746 on in vitro diagnostic medical devices – NB 0124 DEKRA Certification GmbH Germany