MRM | HealthTech Pro B.V.

 

As registered professional organization we supports you in your efforts to comply regulatory requirements of the EU, Canada and the US; and to bring your medical device on the market.

Including:

  • (EU) 2017/745 - MDR (CE Marking medical device)
  • (EU) 2017/746 - IVDR (CE Marking in vitro diagnostic device)
  • MDR/IVDR + Article 15 (PRRC – ‘Person Responsible for Regulatory Compliance’)
  • 'Responsible Person' as required by the MHRA (after the Brexit) 
  • 510(k)
  • Clinical evaluation 
  • PMS / Vigilance processes / PMCF
  • EU Authorized Representative services
  • FSC (Free Sales Certificate)
  • Quality Management System (ISO 13485)

Please contact us for more information.

FullServiceModel MRM

 

The deadline for compliance completion in accordance with the new EU Medical Device Regulation (EU) 2017/745 by medical device manufacturers is 26 May 2020.

This means that your company has limited time to:

1)      Implement an ISO 13485 Quality Management System

2)      Update product technical documentation file, that will need to include far more technical information than ever before.

The New EU Medical Device Regulation (EU) 2017/745 is NOT a new regulation that covers the old medical device directive 93/42/EEC (MDD) with a few changes and updates.  This new document is the result of four  years of re-writing of medical regulatory requirements by the EU Authorities and includes registration and documentation upload in the EU Databank, including pre-clinical and clinical data, post-market surveillance plan and documentation, major changes to labeling including UDI codes, etc. etc.

Taking into account that it takes the average small manufacturer about ten to twelve months to implement an ISO 13485 quality management system and at least six months minimum to prepare a new technical  documentation file, the time has come to start the process immediately.

If you have any questions, or need any assistance, please let us know.

We stand ready to submit our proposal if you are interested.

News

  • BREXIT impact
    How medical devices are currently regulated All medical devices are subject to EU legislation, which requires a manufacturer to place a CE mark on their product to attest compliance to applicable standards. Medical devices are regulated under Directive 90/385/EEC on active implantable medical devices (AIMDD), Directive 93/42/EEC on medical devices…

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