UK Medical Device Registration Overview

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The UK Medical Device Classification

The UK Medical device classifications are based on the UK MDR 2002. Classifying the device is the very first step in the entire process of obtaining approval and launching it in the market.

Medical Device Classification

ClassRisk
Class ILow
Class IIaMedium
Class IIbMedium
Class IIIHigh

IVD Classification

  • General IVD
  • Self-testing IVDs
  • IVDs considered under Annex II List A
  • IVDs considered under Annex II List B

Our company specializes in medical device classification. Freyr has successfully completed device classification for over 50 companies to date in the UK.

United Kingdom Responsible Person (UKRP) Services

Non-UK manufacturers are now required to appoint UKRP mandatorily to place the products in the market.

Freyr has successfully registered and can now act as your UKRP. To get more details on our UKRP services, please visit – www.ukrpservices.com

Medical Device Registration

The manufacturers will now have to appoint a UK-approved body to obtain UKCA marking. Though CE marking is allowed, it is applicable only for a certain time period. The transition timelines for the same are mentioned below –

Freyr is currently supporting many manufacturers with the post-brexit transitions.

*The current transition timeline for CE marking under EU MDR/EU IVDR is recognised by UK MHRA and the timelines will differ as per the scope of the devices

Post-market Surveillance Requirements

Post-market surveillance requirements under UK MDR 2002 are quite stringent to ensure patient/user safety and effectiveness.  Currently, the PMS activities include reporting of incidents/findings to the MHRA. The MHRA has released comprehensive guidance on the same.

UK Medical Device Registration

Freyr Expertise

  • UK Medical Device Classification
  • Regulatory Transition Support concerning post-brexit
  • Regulatory Support for UK MHRA Notification
  • United Kingdom Responsible Person (UKRP)
  • Health Agency and Approved Body liaising and support

Our Location in United Kingdom

9 Greyfriars Road,
Reading, RG1 1NU, UK