This document has been endorsed by the Medical Device Coordination Group (MDCG) 
established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of 
representatives of all Member States and it is chaired by a representative of the European 
Commi ssion.  
The document is not a European Commission document and it cannot be regarded as 
reflecting the official position of the European Commission. Any views expressed in this 
document are not legally binding and only the Court of Justice of the European Union can give 
binding interpretations of Union law.  
1 
 MDCG 2019- 7 
Guidance  on Article 15 of the Medical Device Regulation (MDR) and 
in vitro Diagnostic Device Regulation (IVDR) regarding a ‘person 
responsible for regulatory compliance’ (PRRC)  
Manufacturers1 (paragraph 1)  
“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:   
(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;  
(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. ” 
Clarification on qualifications  
It shall be noted that : 
- For the purpose of fulfilling the requirement laid down in point “ a” of Article 15 
(1), any qualification acquired outside the EU, including any university diplomas 
or certificates, should have been recognised by an EU Member State as 
equivalent to the EU corresponding qualification.  
                                                           
1  Enterprises which employ at least  50 persons and whose annual turnover and/or annual balance sheet total 
exceeds EUR 10 million (Commission Recommendation 2003/361/Ε C of 6 May 2003) . 2 
 - Professional experience in regulatory a ffairs or in quality management systems 
relating to medical devices  should be related to the EU requirements in the field .  
Meaning of “within their organisation”  
The person responsible for regulatory compliance (PRRC) appointed would need to 
be an employee of the organisation.  
Organisations with more than one legal manufacturer  
Organisations with more than one legal manufacturer under the parent company would 
need to ensure that each legal manufacturer has its own PRRC.2 
Can the PRRC be located out side the EU?  
As to the location of the PRRC, it is important that a close linkage, of a permanent and 
continuous nature, is established between the PRRC and the manufacturing activities. 
For this reason,  for manufacturers located outside the EU, it must be assumed that the 
PRRC should also be located outside the EU. On the other hand, for manufacturers 
located in the EU, it must be assumed that the PRRC should also be located in the EU.  
Micro and small manufacturers3 (paragraph 2)  
“Micro and small enterpri ses within the meaning of Commission Recommendation 
2003/361/EC 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 .” 
Meaning of “permanently and continuously at their disposal”  
The micro or small enterprise may subcontract the responsibilities of a person 
responsible for regulatory compliance to a third party, so long as the qualification 
criteria is met and the manufacturer can de monstrate and document how they can 
meet their legal obligations. For example, the PRRC may be part of an external 
organisation, with which the manufacturer has established a contract lay ing down 
provisions so as to ensure the permanent and continuous availability of that party. The 
contract should mention the relevant person’s qualifications allowing compliance with 
points a and b of Article 15 (1).  
Can the PRRC be located outside the EU?  
For micro or small enterpr ises located in the EU, it must be assumed that any person 
to be permanent ly and continuously at their  disposal should be also located in the EU . 
                                                           
2  In the context of Article 15, the obligation for having available within the organisation at least one PRRC refers 
to the individual legal manufacturer.  
3  Enterprises which employ fewer than  50 persons and whose annual turnover and/or annual balance sheet 
total does not exceed EUR 10 million (Commission Recommendation 2003/361/ΕC of 6 May 2003) . 3 
 Authorised representatives (paragraph 6)  
“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 followi ng 
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 medical devices;  
(b) four years of professional experience in regulatory affairs or in quality management 
systems relating to medical devices. ” 
Meaning of “permanently and continuously at their disposal”  
The authorised representative may subcontract the responsibilities of a person 
responsible for regulatory compliance to a third party, so long as the qualification 
criteria is met and the authorised representative can demonstrate and document how 
they can meet their legal obligations. For example, the PRRC may be part of an 
external organisation with which the authorised representative has established e a 
contract laying down provisions so as to ensure the permanent and continuous 
availability of that party.  The contract should mention the relevant person’s 
qualifications allowing compliance with points a and b of Article 15 (1).  
Can the PRRC be located outside the EU?  
Taking into account that the Authorised Representative is located in the EU, it must be 
assumed that any person to be permanently and continuously at its disposal should be 
also located in the EU . 
Roles and responsibilities of the person r esponsible for regulatory compliance 
within a manufacturer (paragraph 3)  
For the purpose of this position paper, the roles and responsibilities of a PRRC have 
been cross -referred to the roles and responsibilities of a manufacturer, as stated in 
Article 10 of the MDR and IVDR. This paper does not interpret the roles and 
responsibilities of a PRRC. We recommend that any guidance on post -market 
surveillance, vigilance, clinical investigations and performance studies, created at a 
European level, should cross -refer to Article 15, paragraph 3 to provide guidance on 
what a PRRC of a manufacturer would be expected to do in these areas.  
  4 
 “The person responsible for regulatory compliance shall at least be responsible for 
ensuring that:  
(a) the conformity of the dev ices is appropriately checked, in accordance with the 
quality management system under which the devices are manufactured, before a 
device is released; ”  
Manufacturers “of devices, other than investigational [performance study] devices, 
shall establish, document, implement, maintain, keep up to date and continually 
improve a quality management system that shall ensure compliance with this 
Regulation in the most effective manner and in a manner that is proportionate to the 
risk class and the type of device” (Article 10(9) of the MDR and Article 10(8) of the 
IVDR).  
“(b) the technical documentation and the EU declaration of conformity are drawn up 
and kept up- to-date; ” 
Manufacturers “[of devices other than custom -made devices] shall draw up and keep 
up to date technical documentation for those devices” (Article 10(4) of the MDR and 
IVDR) and “shall draw up an EU declaration of conformity” (Article 10(6) of the MDR 
and Article 10(5) of the IVDR).  
“(c) the post -market surveillance obligations are complied with in accordance with 
Article 10(10) [Article 10(9) of the IVDR]; ” 
Manufacturers “of devices shall implement and keep up to date the post -market 
surveillance system” (Article 10(10) of the MDR and Article 10(9) of the IVDR).  
“(d) the reporting obligations ref erred to in Articles 87 to 91 [Article 82 and 86 of the 
IVDR] are fulfilled; ” 
Manufacturers “shall have a system for recording and reporting of incidents and field 
safety corrective actions as described in Articles 87 and 88” (Article 10(13) of the MDR 
and Article 10(12) of the IVDR).  
“(e) in the case of investigational devices, the statement referred to in Section 4.1 of 
Chapter II of Annex XV [Section 4.1 of Annex XIV of the IVDR] is issued. ” 
Manufacturers shall ensure that “a signed statement by the natural or legal person 
responsible for the manufacture of the investigational device [for performance study] 
that the device in question conforms to the general safety and performance 
requirements apart from the aspects covered by the clinical investigati on [performance 
study] and that, with regard to those aspects, every precaution has been taken to 
protect the health and safety of the subject.”  
  5 
 Roles and responsibilities of the person responsible for regulatory compliance 
within an authorised represent ative (paragraph 3)  
The PRRC of an AR should be responsible for ensuring that the tasks of an AR  as 
specified in the given mandate, in accordance with Article 11(3), are fulfilled. . 
Can one individual be the PRRC for a manufacturer and its authorised representative?  
The person responsible for regulatory compliance for an authorised representative and 
for an 'outside EU' manufacturer cannot be the same person. There is a clear desire 
within the Regulations for the authorised representative to be adding an additional level 
of scrutiny and ensure that the supervision and control of the manufacture of devices, 
and the relevant post -market surveillance and vigilance activities  are adequately 
effected. If the two roles were conducted by the same person, the additional level of 
scrutiny would be undermined.  
For the same reason, the PRRC of a micro or small enterprise and the PRRC of the 
authorised representative of that same enterprise shall not belong to the same external 
organisation.