Medical Devices and In-Vitro-Diagnostics Regulatory Affairs
Navigating the global landscape with confidence
Person responsible for regulatory compliance (PRRC)
PLG can support:
- European Union (EU) manufacturers
- EU Authorized Representative for:
- Defining PRRC functions
- Appointing PRRC
- Quality technical agreement (QTA) definition
- Quality management system (QMS) support
Who needs a PRRC?
Every manufacturer and EU Authorized Representative must have a PPRC. Manufacturers are required to confirm that their EU representative has appointed a person who meets PRRC qualifications as outlined in Article 15 of the medical devices regulation. If a company consists of more than one legal manufacturer, each legal manufacturer must appoint its own PRRC.
Outsourcing the PRRC:
PRRC functions can be outsourced through an appropriate quality or technical agreement because the role of the PRRC needs to be included in the quality management system and the PRRC requires access to all main documentation in order to support compliance with procedures, technical documentation, and postmarket obligations.
UK Responsible Person
PLG supports you in:
- Defining the UK representative’s functions
- Appointing a UK representative
- Establishing a QTA definition
- Managing the QMS
Who needs a UK representative?
Every non- UK manufacturer, importer, and distributor must have a UK representative. Manufacturers are required to provide documentary evidence that their UK representative has is established in the UK, as outlined in the Medical Devices Regulations 2002 from the Medicines and Healthcare products Regulatory Agency (MHRA)
Outsourcing the UK representative:
The UK representative’s functions can be outsourced through appropriate quality or technical agreements because the role must be included in the QMS and because the representative must have access to all main documentation to support compliance with procedures, technical documentation, and postmarket obligations.
MDR and IVDR strategic support
- 19 European Notified Bodies have been designated under Medical Devices Regulation (MDR).
- 4 European Notified Bodies have been designated under the In Vitro Diagnostic Regulation (IVDR).
PLG helps you determine the best regulatory affairs strategy for managing medical devices requirements in the European Union (EU) and the United States and for EU registration of products by both EU and non-EU manufacturers—from class I to class III. Our team can support the registration of software as a medical device (SaMD) either alone or in combination, including drafting different pathways toward software development and various ways of compliance with current Good Manufacturing Practice regulations.