Contents of Annex XIV of the MDR

Annex XIV of the Medical Device Regulation (MDR) deals with the requirements for clinical evaluation and post-market clinical follow-up (PMCF) of medical devices.

The annex is divided into two main parts: Part A and Part B.

What does Annex XIV of Regulation (EU) 2017/745 (MDR) contain and why is it important for medical device manufacturers?

Part A: Clinical evaluation

1. clinical evaluation plan (CEP)::

• Manufacturers must prepare a detailed plan for the clinical evaluation. This plan must include the objectives, methods and clinical data to be assessed.
• The plan should also include the identification of relevant general safety and performance requirements (GSPRs).

2. conducting the clinical evaluation:

• The clinical evaluation must be conducted in a systematic and methodical manner to demonstrate the safety and performance of a device.
• All available clinical data, including data from clinical investigations, scientific literature and clinical experience, must be considered.

3. clinical evaluation report (CER):

• The results of the clinical evaluation must be documented in a report. This report should include a summary of the clinical data, an assessment of the clinical evidence and a conclusion on the safety and performance of the device.

Part B: Post-market clinical follow-up (PMCF)

1. PMCF plan:

• Manufacturers must establish a post-market clinical follow-up plan. This plan should include the methods and procedures for continuous monitoring of the safety and performance of the device.
• The PMCF plan should also include the identification of potential risks and the measures to monitor and minimise them.

2. implementation of the PMCF:

• PMCF activities must be conducted proactively and systematically to collect and evaluate new clinical data.
• The data collected should be used to update the clinical evaluation and ensure that the product continues to be safe and perform well.

3. PMCF report:

• The results of the PMCF must be documented in a report. This report should include a summary of the data collected, an assessment of the new clinical evidence and a conclusion on the continued safety and performance of a device.

Medical device manufacturers will ensure that their clinical evaluation and PMCF processes comply with the requirements of Annex XIV of the MDR.

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