Medical Devices Regulation · 32017R0745 · every version of this act · on EUR-Lex (external, EUR-Lex)
4 changes recorded across 4 versions, newest first.
Follow this provision (Atom) · Watch it from CI · Watch this provision
Amended by Regulation (EU) 2024/1860 32024R1860 on EUR-Lex (external, EUR-Lex)
Applies from: no date changed
Explanation, written by a model and checked against the cited text
The after text adds a new paragraph 13 stating that Article 10a also applies to devices referred to in paragraphs 3a and 3b of Article 120, a provision not present in the before text.
Cited: Art. 120, v2 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, before and after
Previous version, in force 20 March 2023 02017R0745-20230320 → this version, in force 9 July 2024 02017R0745-20240709
Article 120
Transitional provisions
1. From 26 May 2021, any publication of a notification in respect of a notified body in accordance with Directives 90/385/EEC and 93/42/EEC shall become void.
2. Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC … 1,550 unchanged words … reporting of serious adverse events and device deficiencies shall be carried out in accordance with this Regulation.
12. Until the Commission has designated, pursuant to Article 27(2), issuing entities, GS1, HIBCC and ICCBBA shall be considered to be designated issuing entities.13. Article 10a shall also apply to devices referred to in paragraphs 3a and 3b of this Article.
Amended by Regulation (EU) 2023/607 32023R0607 on EUR-Lex (external, EUR-Lex)
Applies from: not readable (the text changed beyond its dates, so no date that moved can be read as the application date) why
dates added to the text: 2023-03-20, 2024-09-26, 2026-05-26, 2027-12-31, 2028-12-31 · dates removed: 2024-05-27, 2025-05-26
Explanation, written by a model and checked against the cited text
The single 2024/2025 sunset dates for certificates and devices under the old paragraphs 2 to 4 are replaced by a more detailed set of risk-class-based deadlines running through 2027 and 2028, together with new conditions on certificate validity and on when manufacturers must have signed agreements or lodged applications with notified bodies.
New paragraphs 3a through 3f are introduced, setting out specific placing-on-the-market deadlines by device class, conditions for extended validity, post-market surveillance rules, surveillance transfer arrangements between notified bodies, and a separate rule for class III custom-made implantable devices.
Paragraph 4 is reworded so that continued availability on the market or putting into service of devices already placed under paragraphs 3, 3a, 3b and 3f is no longer tied to the previously stated end date.
Cited: Art. 120, v1 (external, EUR-Lex) · Art. 120, v2 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, on this version's page
Amended by Regulation (EU) 2020/561 32020R0561 on EUR-Lex (external, EUR-Lex)
Applies from: 2021-05-26
dates added to the text: 2021-05-26 · dates removed: 2020-05-26
Explanation, written by a model and checked against the cited text
The dates of 26 May 2020 appearing throughout paragraphs 1, 3, 4, 5, 6, 10 and 11 have each been replaced with 26 May 2021, while all other dates in the article remain unchanged.
Cited: Art. 120, v1 (external, EUR-Lex) · Art. 120, v2 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, on this version's page
no amending act named
Applies from: not readable (the text changed beyond its dates, so no date that moved can be read as the application date) why
dates added to the text: 2024-05-26, 2025-05-26 · dates removed: 2025-05-27
Explanation, written by a model and checked against the cited text
Paragraph 3 now specifically extends to class I devices under Directive 93/42/EEC whose declaration of conformity was drawn up before 26 May 2020 and whose conformity assessment under the Regulation requires a notified body, sets a placing-on-the-market or putting-into-service deadline of 26 May 2024, and ties continued compliance to 26 May 2020 rather than to the Regulation's date of application.
Paragraph 4's end date for continued market availability or putting into service moves from 27 May 2025 to 26 May 2025, and its reference to devices placed on the market by virtue of a certificate under paragraph 2 is replaced with a reference to devices placed on the market pursuant to paragraph 3.
Paragraph 8 now also derogates from Article 11(5) of Directive 90/385/EEC and Article 16(5) of Directive 93/42/EEC and adds compliance with Article 31(1) of the Regulation alongside Articles 29(4) and 56(5), while paragraph 10 drops the reference to point (f) of Article 1(6), retaining only point (g); paragraph 6 also replaces "prior 26 May 2020" with "prior to 26 May 2020."
Cited: Art. 120, v2 (external, EUR-Lex) · Art. 120, v1 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, on this version's page