MDR Article 15

Article 15

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.

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.

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.

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.

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.

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.

Explanation

The MDR includes a requirement that applies to all medical device manufacturers, and that is to have a PRRC, which is short for Person Responsible for Regulatory Compliance. So, the regulators believe that introducing this requirement for the European market will ensure the compliance of the manufacturers to the MDR requirements. In article 15 you can read:

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.

Qualifications of the PRRC

Either of the following qualifications shall demonstrate the requisite expertise. Evidence of formal university qualification in either:

  • Law,
  • Medicine,
  • Pharmacy,
  • Engineering, or
  • other relevant scientific discipline

AND

  • At least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices.

OR instead of both things above:

  • Minimum four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.

You can find the full text of article 15 above. These are the formal qualification requirements for the PRRC. Make sure you have records supporting the qualifications of the appointed PRRC.

Responsibilities of the PRRC

The PRRC shall at least be responsible for ensuring that:

  • The conformity of the device is appropriately checked, in accordance with the requirements of the quality management system under which the device is manufactured, before a device is released. Meaning controlling the release of continuous manufacturing.
  • The technical documentation (the TD) and the EU declaration of conformity are drawn up and kept up to date.
  • The post-market surveillance obligations (PMS) are complied with in accordance with Article 83.
  • The reporting obligations referred to in Articles 87 to 91 are fulfilled, which are basically the requirements for Vigilance
  • The case of investigational devices (that is, devices for clinical investigations), the statement referred to in Section 4.1 of Chapter II of Annex XV is issued, which is a signed statement for the manufacture of the investigational device that the device conforms to the GSPR requirements.

The requirement to have a PRRC does not mean that the top management of the medical device manufacturers can avoid caring about the requirements of the MDR. It is always top management, and ultimately the CEO, that has the legal responsibilities for the medical devices under the manufacturer’s name. The PRRC is” just responsible” for governing that the manufacturer does fulfil the specific requirements mentioned above.

Can the PRRC be a consultant?

But what if you are representing a small company, and you don’t have any employees that qualify to take on the role of PRRC? There is a solution to that issue in the MDR; in article 15 micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC shall not be required to have the person responsible for regulatory compliance within their organisation. Still, they shall have such person permanently and continuously at their disposal. The definition of a small enterprise is: less than 50 employees or less than 10 million Euro in the balance sheet.

Registering the PRRC in EUDAMED

The PRRC must be specified in EUDAMED when the manufacturer registers in EUDAMED to get their SRN. And it will be an obvious thing for a notified body to control. And for those who want to read some clarifications regarding PRRC there is an MDCG endorsed document available on this subject.

Relevant courses

Find out more about the requirements by registering for the MDR course below:

Relevant templates

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Applicable MDCG guidance documents

Relevant blog posts

YouTube videos

About the author

Pontus Gedda - Medical Device HQ instructor

Pontus Gedda

Pontus Gedda is a dedicated medical device specialist that has worked both in the industry, as a design engineer and project manager, and in the notified body world as a medical device lead auditor and manager.

He has vast experience in the MDR and its implementation through hands-on experience from implementing the MDR at a notified body and leading that notified body through a joint assessment and getting designated as an MDR notified body.

He was a senior manager at a notified body during the transition from MDD to MDR and also a member of the NB-MED group.

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