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EU: Joint implementation/preparedness plan published
The EU has published a "joint implementation/preparedness plan" for the MDR, which presents the current status and priorities of the further activities regarding the implementation of Regulation (EU) 2017/745.
EU: Tenth notified body for the MDR
The tenth notified body for the MDR has been announced and entered in the Nando database – Norwegian organisation DNV GL Presafe AS.
EU: Documents on European Medical Device Nomenclature (EMDN) published
The EU has published two documents on the new European nomenclature for medical devices that is to be introduced: A brief opinion regarding EMDN and a document on the principle of the underlying Italian CND nomenclature.
The MDCG has published new guidance on cybersecurity with respect to medical devices in the form of MDCG 2019-16.
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On 27th December 2019, the EU published the second corrigendum relating to the MDR and IVDR in the Official Journal of the EU.
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EU: Additional bodies announced for the MDR and IVDR
MEDCERT, a body for the MDR, and BSI Group The Netherlands B.V., a body for the IVDR, are the two newest notified bodies. With these new additions, there are now nine notified bodies available for the MDR and three for the IVDR.
EU: Guidance for Class I manufacturers published
The MDCG has published MDCG 2019-15, a guidance document for manufacturers of Class I products; it provides a step-by-step guide to the required tasks for placing a Class I medical device on the European market.
Germany: Implant register law published in the German Federal Law Gazette
The law on the creation of the implant register was published in the German Federal Law Gazette on 17th December 2019. This hereby introduces the German Law on the Implant Register (IRegG). Its date of application is 1st January 2020.