New “rolling plan” and new guidance documents in relation to the MDR and IVDR

Hogan Lovells
Contact

The European Commission just published an “implementing measures rolling plan” in relation to the MDR and IVDR which are scheduled to apply from 26 May 2020 and 26 May 2022 respectively. New guidance documents concerning the UDI system are also available on the European Commission website.

The rolling plan

The rolling plan contains a list of “essential implementing acts and actions” which must be put in place by the European Commission during the transitional period together with relevant information on expected timelines and state-of-play.

The first part of the plan is dedicated to Implementing Acts concerning the reprocessing of single-use medical devices, common specifications for products without a medical purpose, expert panels, expert laboratories, EU reference laboratories, designation of issuing entities for the UDI system, EUDAMED and the common specifications for Class D in vitro diagnostic medical devices. The second part of the plan relates to other actions/initiatives which will also be important for the application of the MDR and IVDR (e.g. notified body designation, implementation plan and functional specifications of EUDAMED).

The document will be revised by the European Commission on a quarterly basis to provide updated information to the competent authorities and stakeholders.

New guidance concerning the UDI system

New guidance documents endorsed by the Medical Device Coordination Group (MDCG) have also been published on the European Commission website:

  • MDCG 2018-3 “Guidance on UDI for systems and procedure packs”
  • MDCG 2018-4 “Definitions/Descriptions and formats of the UDI core elements for systems or procedure packs”
  • MDCG 2018-5 “UDI Assignment to Medical Device Software”
  • MDCG 2018-6 “Clarifications of UDI related responsibilities in relation to Article 16”
  • MDCG 2018-7 “Provisional considerations regarding language issues associated with the UDI database”

[View source.]

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations. Attorney Advertising.

© Hogan Lovells

Written by:

Hogan Lovells
Contact
more
less

PUBLISH YOUR CONTENT ON JD SUPRA NOW

  • Increased visibility
  • Actionable analytics
  • Ongoing guidance

Hogan Lovells on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide
- hide