Implementation of Medical Device Regulation

Are you ready for May 26, 2021?

No, you haven't forgotten a birthday. May 26, 2021 is the day when you must meet the new MDR requirements.

New legislation

Medical Device Regulation (MDR), 2017/745 comes into force 26 May 2021. The new legislation will change the life of every actors who are part of the supply chain of medical devices.

Is your business ready for May 26, 2021? AlfaNordic can review the quality system and product portfolio and provide a way to meet the new requirements. We can also help with the work or the project management.

MDR should be on the agenda

MDR should be on the agenda of all organizations involved in medical devices: manufacturers, representatives, importers and distributors. There are also products that under MDD were not medical devices, but will be medical devices under MDR!

In addition to gap analyzes, AlfaNordic can develop the MDR implementation strategy to make the best use of the transitional arrangements. We can also be responsible for the project management and not least implement the changes in the organization. Without proper implementation you will fail your next audit, as MDR has a much greater focus on implementation compared to MDD.

Beside MDR and MDD knowledge, AlfaNordic has expertise in these areas:

  • Quality systems, ISO 13485
  • Post Market Surveillance (PMS)
  • Software development, EN 62304CE
  • Risk assessment, ISO 14971
  • Technical documentation and CE labelling
  • Clinical evaluation
  • QP – Qualified Person(s)
  • UDI og EUDAMED
  • Internal and external audits
  • Proces validation (IQ, OQ, PQ)
  • MD og MDR

Contact us

Do you want to know more about the above topic? Do you have a competency inquiry or a specific assignment that you need help with? You are always welcome to contact us directly. 

Ole Markersen
Director, Medical Device, Quality Assurance, Regulatory Affairs & Pharmacovigilance
+45 3144 7511
Email
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