Take Responsibility for Regulatory Compliance
The MDR establishes a new, responsible function: a person responsible for regulatory compliance (PRRC) according to article 15. German medical device manufacturers have already been instituted a similar position in the past. Under the German medical device act (§ 30 MPG), the safety officer was assigned similar but not identical tasks and duties.
In this way, the EU is following the example of personalizing responsibility at medical device companies. Moreover, the scope of responsibility of the article-15-person goes beyond the duties of the safety officer. But it is also stated that a team can share the different issues to manage them all with high quality. For following areas,the PRRC must be accountable:
a) The appropriate verification of conformity of the product before its release in accordance with the quality management system under which the product is manufactured.
b) The compilation of the technical documentation and the EU declaration of conformity and keep them up to date.
c) The compliance with the obligations of post market surveillance in accordance with to article 10(10).
d) The fulfillment of the reporting obligations referred to in article 87 to 91.
e) In case of investigational devices, the statement referred to in section 4.1 of chapter II of annex XV.
How can bear responsibility for regulatory compliance in the company?
As with the safety officer the function cannot be assumed by jus any employee. There are requirements for the qualification. Article 15 paragraph 1a) and b) show the options to demonstrate the qualification:
a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of 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;
b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
Manufacturer of medical devices shall have available at least one person within their organisation who manage the defined obligations. Small enterprises within the meaning of Commission Recommendation 2003/361/EC must not occupy the position internally. But they must have such person permanently and continuously at their disposal.
Also the EU representatives must have a person available who fulfills the minimum conditions of qualification as for manufacturers PRRC.
Do you already have a person responsible for regulatory compliance? We will gladly take over the position for you!