Regulatory Compliance

Person Responsible for Regulatory Compliance (PRRC)

Are you a micro or small enterprise? As stated in Article 15 and MCDG 2019-7 it is not required to have the person responsible for regulatory compliance within your organization, but having such person permanently and continuously at your disposal.

With the required expertise Groots In Vitro Diagnostic Expert is your excellence consultant to act as your PRRC.

Detailed information on the PRRC is included in Article 15 of the IVDR and MCDG 2019-7.

European Authorised Representative (EAR)

Looking for a European Authorised Representative? The European Medical Devices Regulations require manufacturers, without a registered place of business in the EU to designate an authorised representative.

With the required expertise Groots In Vitro Diagnostic Expert Expert is your excellence consultant to act as your EAR.

Detailed information on the Authorised Representative is included in Article 11 of the IVDR.

Regulatory Affairs

Groots In Vitro Diagnostic Expert is your excellence IVDR, MDR and ISO 13485 consultant to ensure quick market access.

  • Expertise as product reviewer for the Notified Body several technical documentation reviews (according to MDD and MDR requirements).
  • Experience with registration processes world-wide, with main focus on Europe, USA 510(k) submissions and Canada.

Do you need support with regulatory compliance?

PRRC
EAR
MDR
ISO 13485