Medical Device Regulatory Services
in United Kingdom
 

Overview

Post-Brexit, the UK is still altering and adding its regulations for medical devices. The regulations to be followed in the country are bifurcated geographically – Great Britain (GB) and Northern Ireland (NI). Medicines and Healthcare Products Regulatory Agency (MHRA) is the regulatory authority that looks after medical device. Northern Ireland is required to European Union Medical Devices Regulations (EU MDR) 2017/745 and In Vitro Diagnostic Devices Regulations (IVDR) 2017/746.

Regulatory Authority: Medicines and Healthcare Products Regulatory Agency (MHRA)

Regulation: Medical Devices Regulations (MDR) 2002

Regulatory Pathway: CE marking followed by Notification

Authorized Representative: United Kingdom Responsible Person (UKRP) for Non-UK manufacturers

QMS Requirement: ISO 13485:2016

Assessment of Technical Data:  UK Approved Bodies for UKCA marking

Valid Markings: GB – UKCA or CE & NI – CE or CE + UKNI

Submission Format: Paper

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.

Device Classification

Classification of the device is the very first step in determining the regulatory pathway for the given product. There are about 22 implementing rules for medical devices and are classified as –

Class

Risk

Class I

Low

Class IIa

Moderate

Class IIb

Moderate to High

Class III

High


Similarly, for IVD, about 7 rules are implemented while classifying into the following four categories –

Class

Risk

Class A

Low

Class B

Moderate

Class C

Moderate to High

Class D

High

 

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.

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.

Freyr has expertise in post-marketing surveillance support in medical writing services.