The European regulation 2017/745 of medical devices will become effective in May 2020 and manufactures, authorized representatives, distributors and all relevant stakeholders involved in medical devices field, will be asked to fulfill new requirements and obligations.
One of the new elements introduced is the Person responsible for regulatory compliance (Article 15).
The presence of this new figure in the company’s organization is mandatory for all manufacturers and for their European authorized representatives.
In order to fulfill the role of person responsible for regulatory compliance, it is necessary to meet specific requirements as concerns educational background and work experience.
These requirements are the following:
- University degree (or a course of study recognized as equivalent by the Member State concerned) in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;
or
- four years of professional experience in regulatory affairs or in quality management systems relating to medical devices (two years for custom-made devices)
The person responsible for regulatory compliance plays a critical role within the company organization, as he/she should ensure that:
- the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
- the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
- the post-market surveillance system is implemented and effective;
- the incidents reporting obligations are fulfilled;
- the statement of general safety and performance requirements compliance of an investigational device is issued (in case of investigational devices only)
It should be highlighted that there may be more responsible persons within the organization, provided that each person is responsible only for one or more of the points listed above and that the division of roles is well described in company’s quality documentation.
Furthermore, it should be pointed out that in certain cases the person responsible for regulatory compliance can be outsourced to third parties (such as consultant).
Regulatory Pharma Net is at your disposal to offer companies additional information and support on quality and regulatory aspects to be compliant to the new Regulation 2017/745.