UK Device Manufacturers
Next Wednesday 26th May 2021 is ‘MDR Day’
ARE YOU READY?

New legislation on medical devices ‘Regulation (EU) 2017/745 (MDR)’ revise the existing framework of the current device directive. The MDR was adopted in May 2017 and will become fully applicable next Wednesday 26th May 2021.

If you are a UK based medical device manufacturer and you sell your devices to the EU, do you know what you have to do? ARE YOU READY?

Examples:

  • Do you have a UK-based PRRC within your organisation, or have you contracted the services of one?

  • Is your technical documentation EU MDR compliant?

  • Do you have a qualified and verified EC REP in place (with their own PRRC)?

  • Have you revised your artwork and IFU?

  • Have you met all the clinical requirements?

If the answer is ‘No’ then you may be looking at major non-conformities.

EU MDR is fully applicable on 26th May 2021 and only the exceptions described under ‘Article 123’ have been given allowances.

If you have any concerns over these or any other aspects of device compliance then come talk to our experienced team of experts.