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.
EU: MDCG publishes additional UDI guidelines
The Medical Device Coordination Group (MDCG) within the European Union has published new guidance documents relating to the UDI, which has been introduced as part of the MDR and IVDR, on the EU websites.
The five new documents, added in October 2018, deal with specific features of systems and procedure packs as well as the associated data elements, the UDI for software as a medical device, clarification regarding the responsibilities in conjunction with Article 16 (transfer of manufacturer's obligations), as well as provisional considerations regarding language rules for the UDI database.
The documents can be found here.
EU: MDCG publishes requirements for medical device nomenclature
Standardised, freely accessible nomenclature for medical devices is being introduced as part of the implementation of the new EU regulation on medical devices (2017/745) and in-vitro diagnostics (2017/756). The Medical Device Coordination Group (MDCG) has now published a requirements profile for this nomenclature, which can be downloaded from the EU website.
EU: Initial guidance documents on UDI implementation published
The Medical Device Coordination Group (MDCG) and the UDI working group (UDIWG) of the EU have published initial documents on the implementation of the Unique Device Identifier (UDI) in accordance with the new European regulations on medical devices (2017/745) and in-vitro diagnostics (2017/756).
A document from the MDCG explains the concept of the Basic UDI-DI and the specifications for changes to the UDI-DI. Two documents from the UDIWG outline the planned structure of the database and the defined data elements.
The documents can be downloaded from the MDCG section of the EU's guidance pages.
The national working group for implementing the European regulations for medical devices (2017/745 MDR) and in-vitro diagnostics (2017/746 IVDR) has published information relating to the sub-groups involved and the current status of the discussions on the website of the Federal Ministry of Health.