MHRA has currently published new guidance on rules that will govern the regulation of medical devices. Here’s a quick overview which can help you to know about the post Brexit medical device regulatory changes for marketing the medical devices in 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.  

What is MHRA Registration and UKCA marking?

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

  • New product marking (UKCA mark) is available. 
  • Medical devices and IVDs need to register with MHRA before placing to 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, 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. 

MHRA registration process: 

 MHRA may ask to provide following details to register the devices: 

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

They may request the further technical documentation as part of 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).  

The medical devices entering to Northern Ireland need to register themselves with MHRA UK and need to follow EU market requirement of MDR or IVDR. From January 1,2021, the new UKCA  (United kingdom conformity Assessments ) Enters to 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 UKCA marking means UK product marking. UKCA 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). 

What are the UKCA marking rules?

Medical device manufacturer needs to use UKCA marking before January1,2023 if the product  

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

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

Summary to remember: 

  • The medical devices to be placed in UK market need to get registered with MHRA within the grace period. CE mark will be recognised till June 30,2023. 
  • If you are outside UK, manufacturer needs to appoint UK responsible person (UKRP) 
  • If the device is CE certified the product /device can be placed in UK market until June30,2023. There will be no need of rebelling. 
  • After June 30,2023 It will be mandatory for the manufacturer to have UKCA mark on their medical device product to be placed in UK market, whereas for NI (Northern Ireland) CE marked devices can be placed even after June 30, 2023. 

What do we do? 

As a medical device consultant, we prepare the technical documentation and make submissions to the notified bodies, co-ordinate with the process and reply to the queries that arise if any to get UKCA marking done. we can assist you  to implement 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, USA, Costa Rica,
Oman,
South Africa & United Kingdom. For free consultation Contact us now.

 

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