Module 16 2022

9/2/2022

Relevant Guidance

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)

• 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 C. Activities undertaken related to PMCF: results Section D. Reference to the relevant parts of the technical documentation Section D. Evaluation of clinical data relating to equivalent or similar devices Section E. 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 applicable common specification(s), harmonized standard(s) or applicable guidance document(s) 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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