Module 15 Presentations

4/15/2024

Transitional Timeline

31 December 2027 - Legacy class III and IIb Implantable devices (except WET) must be MDR certified

26 September 2024 - Manufacturer has formal signed agreement with NB

20 March 2023 - Amendment 2023/607 published in OJ

26 May 2024 -MDR compliant QMS - Formal NB application made

26 May 2026 - Class III custom made devices must be MDR certified

31 December 2028 - Legacy class IIb, IIa, Is, Im and Ir must be MDR certified

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MDR Structure

• Recitals – “whereas” statements (101 statements) • set out the reasons for the content of the articles – why this is happening – statement of purpose • Chapters I – X (Articles 1-123) • “enacting terms”, the normative part of the act – what you need to do – enumerate in detail specific legal requirements • Annexes I – XIII • generally contain rules or technical data which, for practical reasons do not appear in the enacting terms (Articles) – how you do it

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© NAMSA 2021

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