Healthcare Quality and Regulatory Services

EU MDR Date of application, 26/05/2020 is fast approaching.  Are you ready to implement the transition of CE certificates from MDD to MDR?

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See this article from MDDI

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Contact Specialist consultant for Gap Analysis if you comply for:

1. GSPR

2. UDI / GS1 (SRN)

3. Labelling

4. PMS requirements including CER

5. and, other territory requirements

Eudamed is non-operational until 26/05/2022 so what to do till then for compliance for device registration (SRN).

Using 'Declaration of Equivalence' for OEM's UDI-DI, Distributor's GTINs' and align with CA's reference (SRN) as appendix under Product Description of PTD gives satisfactory compliance.

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See this knowledge share from Emergo

We have observed with most of clients that NB have been diligent in reviewing the MDD compliance of QMS and product TF.  The findings raised are often intended for MDR readiness.  See our templates that assist in quick implementation and contact us for more support.

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See our blog for templates and keep checking for new updates.