1. Developments related to future EU Nomenclature 14 December 2018

2. Directive 90/385/EEC on active implantable medical devices
The new EU Regulations on medical devices
(adopted 5 April 2017 and published 5 May 2017)
Directive 90/385/EEC on active implantable medical devices
Directive 93/42/EEC on medical devices
Regulation on medical devices (MDR)
Directive 98/79/EC on in vitro diagnostic medical devices
Regulation on in vitro diagnostic medical devices (IVDR) 2

3. Transitional period May-2017 May-2020 May-2022
Publication of Regulations in Official Journal of European Union and entry into force
Full application of MDR at 3 years (after entry into force)
Full application of IVDR at 5 years (after entry into force)

4. Medical devices nomenclature
The text of Article 26 of the new Regulation
To facilitate the functioning of the European database on medical devices ('Eudamed') as referred to in Article 33, the Commission shall ensure that an internationally recognised medical devices nomenclature is available free of charge to manufacturers and other natural or legal persons required by this Regulation to use that nomenclature. The Commission shall also endeavour to ensure that nomenclature is available to other stakeholders free of charge, where reasonably practicable.

5. Regulatory use of nomenclature
The text of Part B – Core data elements to be provided to the UDI Database together with the UDI-DI in accordance with articles 28 and 29
The manufacturer shall provide to the UDI database the UDI-DI and all of the following information relating to the manufacturer and the device: …
8. the medical device nomenclature code as provided for in Article 26.
NB: Given the investment associated with the making available of nomenclature, it is the intention of the Commission to use the nomenclature in other contexts.
NB: Article 28(3) indicates that the core data elements shall be accessible to the public free of charge

6. Developments related to nomenclature
Task-force established under the UDI WG - composed of regulators from DE, IE, IT, UK – to support the Commission in the selection process
The task-force has been working on gathering relevant information and mapping criteria for the future nomenclature
Requirements were adopted by the EU Medical Device Coordination Group (MDCG) – the group composed of high-level experts from EU Member States advising on all matters related to implementation:

7. Extracts from MDCG 2018-2 document

8. Extracts from MDCG 2018-2 document

9. Latest developments and next steps
The task-force delivered its final report and this was subject to discussion at the MDCG meeting of 30 November
Next steps:
By end 2018/Q1 2019: Decision on the future nomenclature expected

10. THANK YOU!