EU MDR Update

European Union’s Medical Device Regulation (EU) 2017/745

Stay current with EU MDR and other industry developments at Oriel STAT A MATRIX’s blog:
https://www.orielstat.com/blog/

Notified Body Status Report

More Notified Bodies are joining the list. For a list – which we update regularly – visit:
https://www.orielstat.com/blog/eu-notified-bodies-designation-status-mdr-2017-745/

News
• The European Commission opened a website for the European Medical Device Nomenclature (EMDN) codes.
https://webgate.ec.europa.eu/dyna2/emdn/
• Guidance on use of standards in the medical device sector:
https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2021_5_en.pdf
• Q&A on clinical investigation: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-6_en.pdf
• Guidance on alternative technical solutions until EUDAMED is fully functional:
https://ec.europa.eu/health/sites/health/files/md_sector/docs/2021-1_guidance-administrative-practices_en.pdf
• The European Commission is allowing some remote audits for the EU MDR and IVDR on a case-by-case basis.
This action was taken due to the impact of COVID-19 and the need to ensure the continued availability of devices.
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52021XC0111(01)&from=EN
• The EUDAMED actor registration module opened for voluntary registration in December 2020.
https://ec.europa.eu/tools/eudamed/#/screen/home
Fact sheets:
o https://ec.europa.eu/health/sites/health/files/md_eudamed/docs/md_actor_roles_srn_en.pdf
o https://ec.europa.eu/health/sites/health/files/md_eudamed/docs/md_actor_registration_request_process_
en.pdf
• Great Britain (England, Scotland, and Wales) is not adopting the EU MDR; Great Britain will create its own
regulation. https://www.gov.uk/guidance/regulating-medical-devices-from-1-january-2021
• Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19
quarantine orders and travel restrictions: https://ec.europa.eu/docsroom/documents/40705 and questions/answers
about the guidance: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_2020-17-guidance-mdcg-
qa_en.pdf.
• EU MDR Corrigendum: Postpones aspects of EU MDR compliance until 2024 for some Class I manufacturers.
This delay, however, applies only to obtaining new CE certificates and NOT to the QMS requirements in the EU
MDR. This means that a manufacturer of Class I reusable instruments, for example, would have until May 2024 to
assemble their technical documentation, but they still have to comply with all QMS requirements – including the
implementation of postmarket surveillance, risk management, etc. – before the EU MDR goes into effect.
https://www.europarl.europa.eu/meetdocs/2014_2019/plmrep/COMMITTEES/ENVI/DV/2019/12-
02/P8_TA20170107COR02_EN.pdf
• EUDAMED update: Launch postponed to May 2022.
https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/eudamed_en

© 2021 Oriel STAT A MATRIX. All rights reserved.

www.orielstat.com | 1.800.472.6477 2021-5
 PAGE 2

• The IMDRF released three updated guidance documents related to clinical evaluation:
Clinical Evaluation: http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-191010-mdce-n56.pdf
Clinical Investigation: http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-191010-mdce-n57.pdf
Clinical Evidence: http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-191010-mdce-n55.pdf

Guidance Documents
Recent additions include: Q&A on custom-made devices, Is Your Software a Medical Device? infographic, Q&A
about Notified Body audits and COVID-19 impacts, position paper on the use of the EUDAMED actor registration
model and the single registration number (SRN), guidance on the use of MDSAP audit reports, conformity assessment
procedures for protective equipment, UDI for systems and procedure packs, safety reporting in clinical investigations;
PMCF templates; sufficient clinical evidence for legacy devices; clinical evaluation – equivalence; transitional
provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal
product and which has action ancillary to that of the device, as well as on devices manufactured using TSE susceptible
animal tissues; Notified Body audit impact due to COVID-19; changes to UDI-DI.

Find the current list of guidance documents at:

https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en

List of MDCG “works in progress”:

https://ec.europa.eu/health/sites/health/files/md_sector/docs/mdcg_ongoing_guidancedocs_en.pdf

EU UDI Issuing Entities

• GS1
• Health Industry Business Communications Council (HIBCC)
• ICCBBA
• Informationsstelle für Arzneispezialitäten — IFA GmbH

Implementing Acts, Decisions, Regulations

• Commission Implementing Regulation (EU) 2020/1207 of 19 August 2020 laying down rules for the application of
Regulation (EU) 2017/745 of the European Parliament and of the Council as regards common specifications for
the reprocessing of single-use devices (Text with EEA relevance)
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32020R1207&from=EN
• Commission Implementing Decision (EU) 2019/1396 of 10 September 2019 laying down the rules for the
application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the designation
of expert panels in the field of medical devices
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32019D1396&from=EN
• Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to
operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32019D0939&from=EN
• Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the codes for the designation of
notified bodies in medical devices under Regulation (EU) 2017/745 and in vitro diagnostic medical devices under
Regulation (EU) 2017/746
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32017R2185&from=EN

© 2021 Oriel STAT A MATRIX. All rights reserved.

www.orielstat.com | 1.800.472.6477 2021-5