MDCG Guidance for Class I Medical Devices

MDCG Guidance for Class I Medical Devices has now (finally) published its guidance MDCG 2020-2 on the subject, which confirms everything in that blog in terms of the mechanics of timing, but adds important procedural requirements for a class I manufacturer about how to actually document things, what the state of the technical file and QMS should be and what the declaration of conformity should look like, because these are things that manufacturers of class I devices often do not right.

MDCG Guidance for Class I Medical Devices The Medical Device Coordination Group (MDCG), an advisory body of the European Commission, has issued the first revision of guidance notes to the manufacturers of Class I medical devices initially published in December 2019. In particular, the document intends to provide medical device manufacturers and other parties involved with recommendations regarding compliance with the applicable regulations in the context of MDR postponement. 

MDCG Guidance for Class I Medical Devices

The MDCG enlists tasks to be carried out by a Class I manufacturer to ensure compliance with the MDR: Ensure that the device is accompanied by the information needed to identify it and its manufacturer, and any safety and performance information relevant to the user, or any other person, as appropriate.

Implement a post-market surveillance system in accordance with Article 83 (Article 10(10)) proportional to the risk class and appropriate for the type of device, this includes additional aspects to be taken into account in case of devices placed on the market in sterile condition, with a measuring function or that are reusable surgical instruments. This system will be an integral part of the manufacturer’s quality management system based on a post-market surveillance plan.

Implement a system for recording and reporting incidents and field safety corrective actions. Put measures in place to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC3 , without prejudice to more protective measures under national law. These measures will be proportional to the risk class, type of device and the size of the enterprise.

“For devices which are currently certified with respect to the Directive 93/42/EC, and for which the available clinical data are not sufficient to demonstrate compliance with MDR, additional clinical data may be obtained by post-market clinical follow-up studies of the device. Sometimes, even data from the general post-market follow-up might suffice to close the gap.

The MDCG Guidance for Class I Medical Devices says “duly justified and substantiated cases,” some Class I device manufacturers “may exceptionally demonstrate that the conformity with general safety and performance requirements based on clinical data is not deemed appropriate. Such a justification by the manufacturer must be based upon an evaluation of evidence in accordance with Article 61(10). 

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