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New EU guidance sets out guidelines regarding the person that enterprises must appoint as responsible for the enterprise's compliance with the rules in the regulation on medical devices.

The Medical Device Coordination Group (MDCG) issued instructions that clarify the guidelines for a harmonised administrative practice for the interpretation of Article 15 in Regulation 2017/745 on Medical Devices (MDR) regarding persons responsible for compliance with the rules set out in MDR.

The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission. The MDCG was established by Article 103 of MDR and is to provide advice to and assist the Commission and the Member States in ensuring harmonised implementation of the Regulations on Medical Devices.

Manufacturers
Manufacturers are met with the requirement that they must have at least one person in their organisation who is responsible for compliance with MDR rules. This person must have the required professional expertise in the area of medical devices.

Required professional expertise may be based on two different grounds.

Firstly, a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent in law, medicine, pharmacy, engineering or another relevant scientific discipline. Further, at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;

Secondly, the required professional expertise may be obtained through four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.

As the aim is to ensure a close relation between the responsible person and the manufacturer, manufacturers in the EU must have a responsible person who is also in the EU. Similarly, manufacturers outside the EU must have a responsible person, who is also outside the EU.

Micro and small manufacturers
Micro and small manufacturers are enterprises with fewer than 50 employees and revenue of no more than EUR 10m.

Micro and small manufacturers are not required to have a person responsible for regulatory compliance within their organisation. These types of manufacturers may instead keep such a person permanently and continually at their disposal, for instance by concluding an agreement with a third party.

Such third party must comply with the same requirements to professional expertise as persons within the organisations of larger manufacturers.

Authorised representatives
Authorised representatives are similarly not required to have a person responsible for MDR regulatory compliance within their organisation. They may also keep such a person permanently and continually at their disposal, for instance by concluding an agreement with a third party.

Such third party must comply with the same requirements to professional expertise as persons within the organisations of larger manufacturers.

Responsible person's areas of responsibility
The person responsible for MDR regulatory compliance has various areas of responsibility. For instance, the person must ensure that the device is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released. Further, that the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date. The responsible person must also ensure compliance with the post-market surveillance obligations and that the manufacturer has a system for registration and reporting of incidents related to devices.

Click here to read more about the guidance.