Module 16 2024

21/10/2024

What documents/guidance do I need to consider…

• MDR Chapter VI and Annex XIV Part B

• MEDDEV 2.7.1 Rev 4

• MEDDEV 2.12-2

• MDCG 2020-6 (Legacy Devices)

• MDCG 2020-7 (PMCF Plan Template)

• MDCG 2020-8 (PMCF Report Template)

• MDCG 2022-21 (Guidance on PSUR)

• CEN ISO/TR 20416:2020 Medical Devices – Post-Market Surveillance For Manufacturers

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MDCG guidance - Plan and Report

Plan (MDCG 2020-7)

Report (MDCG 2020-8)

Section A. Manufacturer contact details

Section A. Manufacturer contact details

Section B. Medical Device description and specification

Section B. Medical Device description and specification

Section C. Activities related to PMCF: general and specific methods and procedures Section D. Reference to the relevant parts of the technical documentation Section E. Evaluation of clinical data relating to equivalent or similar devices Section F. Reference to any applicable common specification(s), harmonized standard(s) or applicable guidance document(s)

Section C. Activities undertaken related to PMCF: results

Section D. Evaluation of clinical data relating to equivalent or similar devices

Section E. Impact of the results on the technical documentation

Section F. Reference to any common specification(s), harmonized standard(s) or guidance document(s) applied

Section G. – Estimated date of the PMCF evaluation report Section G. Conclusions

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