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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.
http://ec.europa.eu/growth/sectors/medical-devices/guidance/
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.
EU: CAMD (Competent Authorities for Medical Devices) publishes FAQs on the transition to the MDR and IVDR
CAMD, the umbrella organisation for authorities responsible for medical devices in Europe, has published documents on their website containing frequently asked questions about the transition period leading to the EU Regulation on Medical Devices (2017/745 MDR) and In-Vitro Diagnostics (2017/746 IVDR) coming into full effect. These documents address questions about how to handle medical devices and in-vitro diagnostics during the transition period.
MDR: http://www.camd-europe.eu/sites/default/files/media/documents/FAQ_MDR_180117_V1.0.pdf
IVDR: http://www.camd-europe.eu/sites/default/files/media/documents/FAQ_IVDR_180117_V1.0.pdf
EU: Borderline manual on medical devices updated
In December 2017, the European Commission updated its "Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices" to version 1.18. The manual contains examples of the distinction and classification of medical devices and in-vitro diagnostics.
http://ec.europa.eu/DocsRoom/documents/26785/attachments/1/translations/
EU: NBOG publishes a best practice guide to notification in accordance with the MDR and IVDR
The Notified Body Operations Group of the EU has published a guide to best practice, which explains the steps involved in notification and conformity assessment for notified bodies in accordance with the European regulations on medical devices (2017/745 MDR) and in-vitro diagnostics (2017/746 IVDR). This guide contains information on the process of notification, as well as an overview of planned activities and currently estimated timelines in Appendix I.