Role of the Person Responsible for Regulatory Requirements
What is this role?
This is a new regulatory compliance role introduced by the Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746. This is the first time a role of this type is officially recognised and must be appointed by the manufacturer. This is a separate role to that of the Authorised Representative.
How to comply?
Article 15 in the MDR and IVDR is entirely dedicated to the definition of the requirements, tasks and duties of the Person Responsible for Regulatory Compliance. It requires that manufacturers have at least one person responsible for regulatory compliance to be able to perform this role. This person must have the following:
- A formal qualification such as a degree 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 (QMS) relating to medical devices.
- 4 years’ experience in regulatory affairs or QMS related to medical devices.
What are the responsibilities of the role?
- Checking that the device conforms to the manufacturers QMS prior to release
- Verifying that the technical documentation and EU declaration of conformity are properly implemented and maintained
- Managing and ensuring that post-market surveillance obligations are complied with; including post market surveillance plan, post-market report and periodic safety update report as applicable
- Ensuring that the reporting obligations are fulfilled for serious incidents, field safety corrective actions and trend reporting
- The statement referred to in Section 4.1 of Chapter II of Annex XV is issued in the case of investigation devices
Can the role be outsourced?
Yes, however there is only provision for it to be outsourced in micro or small enterprises, these are enterprises which meet the definition of micro or small enterprises as per Commission Recommendation 2003/361/EC. In this scenario, the Person for Regulatory Compliance must be listed as a critical supplier in the manufacturers QMS.
When does this need to be implemented?
The role of Person Responsible for Regulatory Compliance will apply to all devices at the end of the transition period or when CE marking a device to the new MDR/IVDR. It is important that this role is fulfilled within the organisation and that a highly qualified and competent person is in the role of Person Responsible for Regulatory Compliance, as this will ensure that the medical devices remain on the market.
Contact KD&A today to discuss how we might be able to assist you with getting ready for the MDR and IVDR.
June 4, 2020