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Keeping heading to MDR Transition

March 17, 2020

EU MDR Application

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?

See this article from MDDI

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

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Sharma Pokkuluri

Good practices in absence of Eudamed

March 17, 2020

Good practices for SRN and Art.29 2017/745 compliance untill 26/05/2022 

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.

See this knowledge share from Emergo

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Sharma Pokkuluri

Unplanned burden on business

March 17 2020

Nonconformities for MDR Transfer?

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.

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

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Sharma Pokkuluri

Specialty Quality and Regulatory Consultation, UK Ireland and European Medical device Representation, Support client audit and product/process documentation

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