Module 14: Design Development and Certification of Medical Devices

22/11/2023

Application of Standards

• EU Commission implementing decision (EU) 2021/1182 published and amended several times • Generally, the most current standards are considered state of the art • Present a clear gap analysis if older version of standards used • MDCG 2021-5, Guidance on standardisation for medical devices

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Manufacturing & Process Validations

• Full manufacturing validations are required (MDR Annex II, Section 3b)

• Protocols & reports of critical process validations are required, not just summary • Overall summary / Master Validation Plan helpful to understand overall strategy and process • Clear link between PFMEAs, manufacturing processes, incoming inspections and inline tests etc. for completeness and control. • Process validations: what was run, including justifications for tests conducted, sampling rationale, raw data, product range covered.

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