MDR Article 15

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.