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The EU has used implementing decisions to update the lists of harmonised standards relating to Directives 93/42/EEC (medical devices), 90/385/EEC (active implants) and 98/79/EC (in-vitro diagnostics).
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EU: Additional notified body for the MDR
Another notified body for Regulation (EU) 2017/745 (MDR) has been entered into the Nando database – the Hungarian organisation CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft. This brings the total number of notified bodies for the MDR to twelve.
EU: Two new guidance documents published
The MDCG has published two new guidance documents. MDCG 2020-1 deals with clinical evaluation and performance evaluation for software in particular. MDCG 2020-2 contains information about medical devices in Class I, which are subject to the amended transitional provisions of Article 120 (3/4).
The MDCG has updated two of its guidance documents: Version 3 of MDCG 2018-1 on the basic UDI ID is now available; version 2 of MDCG 2019-8 on implant cards is now available.
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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.