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Hitec Medical MDR training – Technical documentation requirements under MDR（Part 2）

Clinical evaluation requirements under MDR

Clinical evaluation: 

Clinical evaluation is the collection, evaluation, and analysis of clinical data through a continuous and proactive approach, utilizing sufficient clinical data to determine compliance with relevant GSPR requirements.

Clinical investigation:

Conduct a systematic survey of human samples to evaluate the performance and safety of medical devices.

PMS（Post market surveillance):

Refers to all activities carried out by manufacturers and other economic operators in cooperation, with the aim of establishing and maintaining the latest systematic procedures to proactively collect and summarize experiences gained from devices that have been launched and are available or put into use in the market, and determine whether necessary corrective and preventive measures need to be understood.

PMCF( Post market clinical follow-up):

A method and procedure for actively collecting and evaluating clinical data on device performance and safety. As part of the technical documentation, PMCF is connected to and used to update the PMS plan and CER. It can also be used as a template for PMCF reports.

MDR Article 10: Manufacturers shall conduct clinical evaluations in accordance with the requirements of Article 61 and Appendix XIV, including post market clinical tracking PMCF.

MDR Article 61: Confirmation of compliance with basic safety and performance requirements should be based on clinical data, as well as data from post market surveillance PMS. Manufacturers should conduct clinical evaluations according to the plan and form written documents.

MDR Article 54: For specific Class III and IIb devices, the notified body shall implement a clinical evaluation consultation process:

Class III implantable devices

IIb active devices that are removed from the human body or administered to the human body in a potentially dangerous manner.

The following situations do not require a clinical evaluation consultation process:

Renew certificates in accordance with MDR regulations;

Modification of products already on the market by the same manufacturer.This modification does not affect the profit risk ratio of the device;

There are relevant CS and the notified body has confirmed compliance the section on clinical evaluation in CS.