Med-Di-Dia

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CORE SERVICES

EU AR / PRRC Services

 

We will be your PRRC or EU AR under the new EU Medical Device and In-Vitro Diagnostic Regulations.

 

EU Authorised Representative

EU Market Access

We can help you successfully CE Mark your device under the Medical Device Regulation and In-Vitro Diagnostic Regulation

 

FDA Regulatory Submission

 

We can be your guide for clearance/ approval of your device in the US under  the 510k, PMA or De Novo routes.

 

ONGOING AND ROUTINE SERVICES

 

Review and approval of all elements of Medical Device and IVD submission data (CE mark & US FDA) including the following:

 

 

Rest of World regulatory and quality compliance expertise is provided by our parent company, Global Regulatory Services (GRS).

LATEST INSIGHTS

EU AI Act and Digital Health

EU AI Act and Digital Health

Would there a major impact on Digital Health?

8.5.2024

How to assign Master UDI-DIs to contact lenses: A new regulation update

How to assign Master UDI-DIs to contact lenses: A new regulation update

The European Commission on 20 October 2023 published an amendment which introduces a new concept of Master UDI-DI for contact lenses.

26.3.2024

eSTAR and Pre Market Approval

eSTAR and Pre Market Approval

On 6th December 2023, the USFDA announced the voluntary use of eSTAR - Electronic Submission Template.

29.2.2024