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Following the draft bill, the Federal Ministry of Health has now published the cabinet draft for the German EU Medical Devices Adaptation Act (MPEUAnpG).
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EU: Additional notified bodies for the MDR announced
The EU has published two new notified bodies for the MDR in the Nando database. These additions mean that there are now seven notified bodies available for the MDR.
According to information on its website, the EU is postponing the launch of the EUDAMED database until May 2022. The date on which the MDR becomes valid in May 2020 remains unchanged.
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The Federal Institute for Drugs and Medical Devices (BfArM) has adopted the updated report forms according to MEDDEV 2.12/1 on its website and announced that their use is mandatory as of 1st January 2020.
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EU: DEKRA named as the first body for the IVDR
In the current EU Nando database, DEKRA Certification GmbH has been announced as the first notified body for the IVDR (2017/746). There are currently five notified bodies available for the MDR and now one body for the IVDR.
EU: MDCG publishes guidance on medical device software
The MDCG has published guidance on medical device software. It explains how software is qualified as medical device software and contains more details about the classification. When doing so, it considers the specifications in both the MDR and IVDR.
EU: MDCG publishes guidance on the format of the Basic UDI-DI
The MDCG has published MDCG 2019-1, which provides guidance on the guidelines for allocation of the Basic UDI-DI by the issuing bodies. It contains just two points: The Basic UDI-DI shall have a maximum of 25 characters and must contain a check digit/character.
As the first notified body for the EU Regulation on Medical Devices, BSI Assurance UK has now been entered into the Nando database under Notified Body number NB 0086.
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