Personal Responsible for Regulatory Compliance

Personal Responsible for Regulatory Compliance

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:

(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;
(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/EC (Micro and SMEs are those  organizations which have less than 50 employees and a turnover of less  than 10 million Euros) 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:

  • 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;
  • the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
  • the post-market surveillance obligations are complied with in accordance with Article 10(9);
  • the reporting obligations referred to in Articles 82 to 86 are fulfilled;
  • 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.

Authorized Representative

Manufacturer  with a registered place of business outside the Union shall designate a  sole authorized representative in order to place their device on the EU  market (Art 11.1).


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