News

Medical device actors can gives their views and contribute to the future UK´s regulatory framework. Since September 16, 2021, the Medical and Healthcare products Regulatory Agency (MHRA) gives the opportunity…

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Submissions for PECP (Performance Evaluation Consultation Procedure) are accepted since September 3, 2021, by the expert panels in the field of in vitro diagnostic medical devices. What are the expert…

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Marked by strong economic development, Asian countries are gradually implementing UDI and regularizing their regulatory environment for medical devices. It is therefore smart to know where these countries are in…

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Which details of the critical warnings have to be provided to EUDAMED, to the GUDID ? The Label information, the instructions for use, or both ? What about the contra…

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The UDI (Unique Device Identification) field is still evolving and is more or less advanced depending on the country. If you are in any way related to the medical devices…

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Our partner Kern AG organizes a free of charges webinar on July 21, 2021 with the participation of Ismail Demiralp as guest lecturer, the CEO of Europe IT Consulting GmbH.Since…

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New differing requirements now apply to EU and Swiss medical device manufacturers.As already mentioned in a previous article (MRA between Switzerland and EU no longer valid), Switzerland is considered as…

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With the implementation of the Medical Device Regulation comes the new EMDN (European Medical Device Nomenclature), as stated in the regulations (Art.26 2017/745 MDR, Art.23 2017/746 IVDR). Review this concept…

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With the entry into force of MDR 2017/745 on 26.05.2021, the agreement on mutual recognition of medical devices between Switzerland and the EU lost its validity. Thus, Switzerland is now…

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Find out here  about the latest status (05/2021) of the UDI implementation for the EUDAMED database. 

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