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 in vitro diagnostic 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 in vitro diagnostic medical devices;

2. (b)

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

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(9);

4. (d)

   the reporting obligations referred to in Articles 82 to 86 are fulfilled;

5. (e)

   in the case of devices for performance studies intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects, the statement referred to in Section 4.1 of Annex XIV 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 in vitro diagnostic 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 in vitro diagnostic medical devices;

2. (b)

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