Essentials of European Medical Device Regulatory Affairs

MDCG Sub-groups

• Post Market Surveillance & Vigilance (PMSV) • International/IMDRF coordination (INT) • Notified body oversight (NBO) • Market Surveillance (MS) • New technologies (NET) and Software • Clinical investigation and evaluation (CIE)

• Annex XVI (no medical purpose products) • In Vitro Diagnostics (IVD) • Unique Device Identification (UDI) • Standards (STAND) • Borderline and Classification (B and C)

The Organisationfor Professionals inRegulatory Affairs

MDCG publications

Topic

Content

Document

UDI

UDI rules for combination products

MDCG 2019-2, February 2019

Guidance in UDI for systems and procedure packs

MDCG 2018-3, October 2018

UDI assignment to medical device software

MDCG 2018-5, October 2018

EUDAMED

Timelines for registration of device data elements in EUDAMED

MDCG 2019-4, April 2019

Registration of legacy devices in EUDAMED

MDCG 2019-5, April 2019

Notified Bodies

Q&A: Requirements relating to Notified Bodies

MDCG 2019-6, June 2019

Application of transitional provisions concerning validity of certificates issued in accordance to the directives

MDCG 2-19 – 10, October 2020

The Organisationfor Professionals inRegulatory Affairs