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The MDCG has issued a new guidance document (MDCG 2020-3) relating to the question of assessing significant changes to products that have been placed in the market in accordance with the further-reaching transitional provisions in Article 120 MDR.
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The Team-NB association of notified bodies has published a position paper on dental implants.
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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.