EU Person responsible for regulatory compliance: new role and responsibilities in companies
As of May 26th, 2020, companies producing medical devices will be required to nominate a person responsible of regulatory compliance. The PRCC supervises and controls the manufacture of devices and carries out the post-market surveillance and vigilance activities. In particular, large manufactures, that is to say enterprises which employ at least 50 people and whose annual turnover and/or annual balance sheet total exceeds EUR 10 million, must have available the PRRC within their organization. Instead, micro and small enterprises and the authorized representatives are not required to have the PRRC within their organization but must have such person “permanently and continuously at their disposal”. But what is his role and responsibilities?
On April 5th, 2017, the UE enacted the Regulations no. 745 and no. 746 relating to medical devices (MDR) and in vitro diagnostic medical devices (IVDR). Both Regulations aim to ensure the smooth functioning of the internal market with regards to the medical devices and in vitro diagnostic medical devices; their primary scope is to keep a high level of health protection for the patients and users. At the same time, the Regulations set high standards of quality and safety for medical devices in order to meet common safety concerns of such products.
Both the Regulations contain specific prescriptions addressed to all economic operators involved in the chain, i.e. device manufacturer, “authorized representative” (according to art. 2, §32, MDR the “authorized representative” is any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under this Regulation. Art. 2, §25, of the IVDR provides for the same definition), importer and distributor, taking also into account the small and medium enterprises that are active in this sector.
In order to ensure that all the prescriptions are fulfilled correctly, the Regulations require that the manufacture and the “authorized representative” appoint (or have at their disposal) a person responsible for the regulatory compliance (PRRC) whose specific role is to supervise and control the manufacture of the devices and to carry out the post-market surveillance and vigilance activities concerning them. Generally, the PRRC has the task to ensure that the obligations of the manufactures and the authorized representative are performed correctly and thus his obligations are strictly related to the manufactures and the authorized representative’s obligations.
Article 15 of the Regulations, in particular, states that the PRRC shall be 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 in accordance with Article 10(10) of the regulation
d) The reporting obligations referred to in Article 87 and 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
Considering the responsibilities that the PRRC assumes, both from a management point of view and from a technical, scientific and legal point of view, the Regulations require that the PRRC must fulfill minimum condition of qualification. Art. 15, §1, states that 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 recognized as equivalent by the Member State concerned, in 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;
b) Four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
The type of appointment of the PRRC is specified by the Regulations themselves and clarified by the Guidance on Article 15 of the Medical Device Regulation and in vitro Diagnostic Device Regulation (this document has been prepared and endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission. The Guidance is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission). In particular, large manufactures, that is to say enterprises which employ at least 50 people and whose annual turnover and/or annual balance sheet total exceeds EUR 10 million (see Commission Recommendation 2003/361/EC of May 6th 2003), must have available the PRRC within their organization, that is to say that the PRRC would need to be an employee of the organization.
Micro and small enterprises (enterprises which employ less than 50 people and whose annual turnover and/or annual balance sheet total does not exceed EUR 10 million. See Commission Recommendation 2003/361/EC of May 2003) and the authorized representatives are not required to have the PRRC within their organization but must have such person “permanently and continuously at their disposal”. This means that it is possible to subcontract the responsibilities of the PRRC to a third party, as long as the qualification criteria is met and the authorized representative can demonstrate and document how they can fulfill their legal obligations. For example, the PRRC may be part of an external organization with which the authorized representative has established a contract laying down provisions that ensure the permanent and continuous availability of that party.