Companies that have CE Marked Medical Devices have a requirement that is unique requirement. Specifically, they need to create a Clinical Evaluation Report or CER for each product or product family. This is a required in Section 6.1 of Annex II in the EU MDR (i.e., Regulation 2017/745). It states that you need to include in your technical documentation (i.e., Technical File) a clinical evaluation report (CER), its updates, and the clinical evaluation plan referred to in Article 61 (12) and Part A of Annex XIV. Part B of Annex XIV is the requirement for a Post-Market Clinical Follow-up.

The plan must have:
1. general safety and performance requirements that require clinical data
2. specification of intended purpose
3. specification of intended target groups with indications and contraindications
4. description of clinical benefits with clinical outcome parameters
5. methods used for examination of qualitative and quantitative aspects of clinical safety (including reference to residual risks and side effects)
6. specification of parameters used to determine acceptability of the benefit-risk ratio for various indications and intended purpose
7. how benefit-risk issues related to pharmaceutical, animal, and human tissues will be addressed
8. clinical development plan indicating the progression

You shall identify available clinical data relevant to your device and any gaps in the clinical evidence through systematic literature review.

You shall appraise clinical data by evaluating suitability for establishing safety and performance.

You shall generate a properly designed clinical investigation according to the clinical development plan.

You shall analyze all relevant clinical data to reach conclusions about safety and clinical performance--including the clinical benefits.

You need to include favorable and unfavorable data.

Your data can be based upon:
1. equivalence data
2. results of clinical investigations
3. a combination of literature review, equivalence data, and any clinical investigations

You must also review post-market surveillance data and evaluate how the clinical data and post-market data address risks in your risk analysis. Updates to post-market data require updating your clinical evaluation report and you may need to update you risk management file based upon the outcome of the clinical evaluation.

You can find the Medical Device Coordinating Group (MDCG) Guidance Documents on the following webpage:
➤ [ Ссылка ]

The methods used in MEDDEV 2.7.1 rev 4 have not really changed, but the Notified Bodies now need to create reports on their assessment of the CER.

A summary of the Clinical Evaluation and PMCF required in Annex XIV must be included in the Summary of Safety and Clinical Performance for Class III and implantable devices (Article 32). These summaries must also be submitted to the MDCG as part of the mechanism for scrutiny of conformity assessments in Article 55.

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