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Recent amendments & corrigenda

Applies to

MDR 2017/745 and IVDR 2017/746 and their amending regulations. This page tracks significant amendments; always verify current status in the Official Journal.

Disclaimer

This site provides general information only. Legislative timelines and requirements change — always verify against the current Official Journal consolidated text.

MDR amendments​

Regulation (EU) 2020/561 — COVID-19 delay​

Published: 23 April 2020 Effect: Delayed the MDR date of application from 26 May 2020 to 26 May 2021, in response to the COVID-19 pandemic's impact on manufacturer and notified body readiness.

Regulation (EU) 2023/607 — Extended transitional provisions​

Published: 15 March 2023 Effect: Major extension of MDR transitional provisions for legacy MDD/AIMDD devices:

  • Class III and implantable Class IIb: certificates valid until 31 December 2027
  • Other Class IIb and Class IIa: certificates valid until 31 December 2028
  • Introduced a mandatory requirement for manufacturers to have signed NB agreements by defined dates
  • Introduced sell-through provisions allowing devices manufactured before certificate expiry to remain on market until 31 December 2028 or 2029

IVDR amendments​

Regulation (EU) 2022/112 — First IVDR transitional extension​

Published: 25 January 2022 Effect: Extended the IVDR transitional provisions for legacy IVDD devices:

  • Class D: certificates valid until 26 May 2025
  • Class C: certificates valid until 26 May 2026
  • Class B: certificates valid until 26 May 2027
  • Class A self-declared: until 26 May 2027

Regulation (EU) 2024/1860 — Second IVDR transitional extension​

Published: 20 June 2024 (OJ L 2024/1860) Effect: Further extended IVDR transitional provisions:

  • Class D: certificates valid until 31 December 2027
  • Class C: certificates valid until 31 December 2028
  • Class B: certificates valid until 31 December 2029
  • Class A self-declared: until 31 December 2030

Recent MDCG guidance updates (2026)​

MDCG 2021-5 Rev.1 Appendix — EC REP to EU REP symbol transition​

Effective: 17 June 2026 Effect: Introduces the transition from the "EC REP" (Authorised Representative) symbol to a new "EU REP" symbol on device labelling, with a 5-year coexistence period during which both symbols remain acceptable. The coexistence period ends 17 June 2031, after which only the EU REP symbol may be used.

MDCG 2026-4 — SSCP/SSP EUDAMED upload responsibility​

Effect: Transfers responsibility for uploading the Summary of Safety and Clinical Performance (SSCP) and Summary of Safety and Performance (SSP) to EUDAMED from notified bodies to manufacturers.

Corrigenda​

Corrigenda correct errors in the original published text. For MDR and IVDR, several corrigenda have been published in the Official Journal correcting translation errors and drafting mistakes across language versions. These are automatically incorporated into the consolidated EUR-Lex text. When citing MDR or IVDR requirements, always reference the consolidated text to ensure you are working from the authoritative, corrected version.

Monitoring for future amendments​

The legislative landscape continues to evolve. Areas where further amendments may occur:

TopicStatus
Additional IVDR Class D transitional provisionsUnder ongoing political discussion
Notified body capacity — legislative responseRegularly reviewed; possible further transitional measures
Annex XVI Common SpecificationsGroups 2–6 CS still in development
AI Act interface with MDRGuidance and possible legislative clarification expected
EUDAMED mandatory use datesPhased implementation continues

→ See Reforms tracker for current monitoring.