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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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EU: Commission updates websites for the new regulations
The EU Commission has updated its websites on the new regulations and created a separate area for the current situation and the upcoming guidance documents. Additional documents, such as the "rolling plan" for the status of the measures (currently here) and an up-to-date overview of the status of the notification process (currently here).
EU: Minutes of MDCG meeting in October 2018
The Medical Device Coordination Group (MDCG) has now published the minutes of its latest meeting. In October 2018, an extraordinary meeting was held regarding the planned corrigendum for the regulations, which is intended to rectify errors and inconsistencies within the texts and translations.
EU: Team-NB publishes a white paper on the situation regarding notified bodies
Team-NB, an association of notified bodies, has published a press release on the status of the notification process for the MDR and IVDR on its website.
Additionally, a white paper has also been published here, once year after notified bodies were first permitted to submit their documents for notification as per the regulation.
EU: Current version of the borderline manual
In October 2018, the EU once again published an updated version of the borderline manual for classification of medical devices and IVD separately from other legal areas.