MHRA has currently published new guidance on rules that will govern the regulation of medical devices. Here’s a quick overview that can help you to know about the post-Brexit medical device regulatory changes for marketing medical devices in the UK market. With a regular demand for imported products, the industry–in addition to the regulatory devices–is receptive to novel and revolutionary technology, which creates huge opportunities for medical device manufacturers in the market.

UKCA marking

MHRA Registration and UKCA Marking

MHRA (The Medicines and Healthcare Products Regulatory Agency) is the medical device regulatory body for the UK medical device market. To place a medical device in Great Britain’s market key requirements are as follows:

  • New product marking (UKCA mark) is available. 
  • Medical devices and IVDs need to be registered with MHRA before being placed on the market. 
  • If a manufacturer is outside of the UK, then he/she needs to appoint a single UK-responsible person. 
  • CE marking will be continued till June 30, 2024. 

The medical devices in the UK are classified as Class I, Class IIa, Class IIb, and Class III   the way the European Union classifies the devices. Class I Medical devices are low-risk devices whereas class III  devices are high-risk medical devices.

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MHRA Registration Process

  • Legal entity name and address 
  • Company Type  
  • Administrative Contact 
  • Class of the device 
  • UDI-DI if applicable 
  • Medical device name  

They may request further technical documentation as part of the scrutiny and data validation process. You can also refer UK government website for more info. The timeline of the medical device registration process will depend upon the class of the device. MHRA allows medical device manufacturers to register their devices via DORS (device online registration system).

Medical devices entering Northern Ireland need to register themselves with MHRA UK and need to follow the EU market requirements of MDR or IVDR. From January 1, 2021, the new UKCA  (United Kingdom Conformity Assessments ) Enters a transitional duration for devices getting into the UK market.

UK CA Marking for Medical Devices

To get placed in UK market medical devices need to have UK CA marking means UK product marking. UK CA stands for UK Conformity Assessed, UKCA marking is a substitute for the EU requirement of CE marking. For the Northern Ireland market CE mark or UKNI mark is required for the placement of medical devices in Northern Ireland market.  

You need to demonstrate that your medical device meets the requirements in the UK MDR 2002 by carrying out a conformity assessment. The assessment route depends on the classification of the device. A UKCA mark is a logo that is placed on medical devices to show they conform to the requirements in the UK MDR 2002.  

Exemptions: One should not put UKCA mark on product if, 

  • The product is exclusively for clinical investigation and meets the requirement as far as possible. 
  • an in vitro diagnostic medical device (IVD) for performance evaluation 
  • a non-compliant device used in exceptional circumstances (humanitarian grounds) 
  • Custom made device which meet the requirement in UKMDR 2002 

The UKCA marking requirement is based on EU legislation such as for active implantable devices EUAIMDD, for medical devices (EUMDD) In vitro diagnostic medical devices (EUIVDD).

UKCA Marking Rules

Medical device manufacturer needs to use UKCA marking before January 1, 2023, if the product  

  • The product is for Great Britain (England, Scotland, Wales) market. 
  • The product requires third-party conformity assessment. 
  • The product is covered by legislation that requires the UKCA marking. 

UK CAs technical requirements, conformity assessment process, and standards to demonstrate conformity are largely the same as CE marking. UK CA marking can be applied on the product itself or the packaging, in some cases, it may place in manuals; It will vary as per the product. UKCA marking must be clear and visible, and UKCA marking must only be placed on the product by a manufacturer. By affixing UKCA marking you take full responsibility for the conformity of the product with the required legislation. There should not be any sign or marking which may misconstrue the meaning of UKCA marking. 

Summary to remember: 

  • The medical devices to be placed in the UK market need to get registered with MHRA within the grace period. CE mark will be recognized till June 30, 2024. 
  • If you are outside UK, the manufacturer needs to appoint UK responsible person (UKRP) 
  • If the device is CE certified the product /device can be placed in the UK market until June 30, 2023. There will be no need of rebelling. 
  • After June 30, 2024, It will be mandatory for the manufacturer to have the UKCA mark on their medical device product to be placed in the UK market, whereas for NI (Northern Ireland) CE marked devices can be placed even after June 30, 2024.

What Do We Do?

As medical device consultants, we prepare the technical documentation and make submissions to the notified bodies, coordinate with the process, and reply to the queries that arise if any to get UKCA marking done. We can assist you in implementing QMS as per the regulatory requirement as we have been providing these services in the medical device regulatory field for more than 12 years. We also provide medical device consultation for India, Saudi Arabia, the USA, the UK, South Africa, Oman, Iran & Egypt. Feel free to contact us.

For more details on the UKCA marking process, you can Contact us or WhatsApp us with your queries, and we will surely answer them.