Article 15

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:

1. (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;

2. (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.

Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC¹ 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.

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

1. (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;

2. (b)

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

3. (c)

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

4. (d)

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

5. (e)

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

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.

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.

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:

1. (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;

2. (b)

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