The introduction of the European Medical Device Regulation (MDR) is nearly here and it will impact every company with a CE mark.

Medical Device Regulation

There will be a three-year transition period for the phasing-in of the MDR, to allow companies to make any necessary changes.

Do you have a plan to address this?

Many forward-thinking medical device companies are already developing their poilicies for compliance now, in order to gain strategic advantages over their competitors.

Regulations are non-negotiable

This will see regulatory departments going into overdrive as they experience an increase in their workload.

Companies should be planning to:

  • Provide more clinical evidence to get new products to market or for high-risk products to get CE marked, or even to keep some existing products on the market.
  • Conduct deep portfolio audits to identify and understand the new regulations. One of the key areas is classification. In the majority of cases, the re-classification is upwards and this will have a commercial impact, with the introduction of Unique Device Identifiers (UDI). Products will have to be relabeled and data made ready to be made publicly available.
  • Conduct a gap analysis.
  • Select a person or establish a team to create an MDR-readiness programme.
  • Support the existing regulatory team and analyse resources (headcount, budget) and provisions.

Regulations are non-negotiable.

And perhaps most importantly, given these changes to the regulations and also the Quality Management System Standards (ISO 13485), you should have already opened discussions with your Notified Body to understand their plans for designation for the MDR.

Companies cannot apply for designation until six months after the MDR’s “entry into force”, which is now expected to be May 2017 and – be warned – the process is not quick.

Companies cannot afford to delay acting on these critical changes.

HC Skills have an online course for Medical Device Regulations as they stand at the moment. As soon as the changes are published, we will incorporate them into the programme.

You can even take the qualification now and brush up later.





Tel: +44 (0) 141 946 6482

Address: Healthcare Skills Training International Ltd
West of Scotland Science Park
Block 7, Kelvin Campus
Glasgow G20 0SP