MDR - Chapter II - article 15

Original text

Expert opinion

Person responsible for regulatory compliance

1. Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices. The requisite expertise shall be demonstrated by either of the following qualifications:

(a) 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 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. Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made devices may demonstrate the requisite expertise referred to in the first subparagraph by having at least two years of professional experience within a relevant field of manufacturing.

The PRRC

The Person Responsible for Regulatory Compliance (PRRC) is a new “person” defined in the MDR and to be made available in an organisation. To make available is understood to employ such a person. The qualification must be demonstrated by data and must be either:

 

a) formal qualification/education in a scientific discipline + 1 year of professional experience in QA/RA in medical devices

 

 

 

or

 

 

b) 4 years of professional experience in QA/RA in medical devices.

For custom-made devices, 2 year experience in relevant manufacturing is sufficient.

 

2. Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC (1) shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person permanently and continuously at their disposal.

Definition of micro- and small enterprises are given in the commission recommendation 2003/361/EC and summarized in this article.

Permanently and continuously at disposal suggests a written contract with a minimal work load depending on the products and their risk classification.

3. The person responsible for regulatory compliance shall at least be responsible for ensuring that:

(a) 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;

(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;

(c) the post-market surveillance obligations are complied with in accordance with Article 10(10);

(d) the reporting obligations referred to in Articles 87 to 91 are fulfilled;

(e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.

PRRC is personally responsible for the following:

 

a) check conformity of every manufactured medical device against the internal SOPs and QMS prior release; preferrably done together with batch release.

b) author the TF and DoC and keep those documentations up-to-date. So, any change or update needs to be implemented into the TF and the DoC renewed if deemed necessary.

c) conduct PMS for every released product

d) report to authorities in cases of serious incidents and field actions (article 87) and keep up-to-date with the typology, the forms and other communication details of serious incidents and field actions (article 91).

e) issue a signed statement that the device conforms to the general safety and performance requirements, apart from clinical investigation aspects, and that every precaution has made to protect the general health and safety.

4. If a number of persons are jointly responsible for regulatory compliance in accordance with paragraphs 1, 2 and 3, their respective areas of responsibility shall be stipulated in writing.

in the case of multiple PRRC, provide a document defining the areas of responsibility per PRRC.

5. The person responsible for regulatory compliance shall suffer no disadvantage within the manufacturer’s organisation in relation to the proper fulfilment of his or her duties, regardless of whether or not they are employees of the organisation.

In order to suffer no disadvantage, the PRRC should be given the authority and responsibility to fulfil its duties. Keep in mind that the PRRC might stop products from being made available to the market and such a decision shall not be penalized in any way.

6. Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements for medical devices in the Union. The requisite expertise shall be demonstrated by either of the following qualifications:

(a) 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 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.

In addition to legal manufacturers, distributors and EC REP’s need a PRRC as well. Unlike as for enterprises, the PRRC for distributors and EC REP’s don’t need to be employees.

Any questions left? Contact Avanti Europe to discuss with an expert