On October 21, 2022, the Medicines & Healthcare Products Regulatory Agency (MHRA) announced that they are adding a twelve-month extension to the current standstill period on future Regulation for Medical Devices, aiming to bring the new regulations into force on July 1, 2024. With the approaching deadline for EU MDR compliance, this is a relieving exhalation for Medical Device Manufacturers. The extension of the United Kingdom Conformity Assessed (UKCA) deadline allows manufacturers to thoroughly prepare for the requirements to obtain UKCA marking. Let’s look at what we know is coming for medical devices in the Great Britain market.
What is UKCA Marking?
The first and most important question: What is UKCA marking? The UKCA mark is the product marking which must be used to demonstrate that a medical device meets the Essential Requirements (ER) of the Medical Devices Regulations 2002, as amended. The Great Britain route to market is based on the requirements derived from the following EU Legislation: Directive 90/385/EEC, Directive 93/42/EEC, and Directive 98/79/EC. UKCA marking came into effect in Great Britain in January 2021 when the UK left the European Union (EU). Until the extended date of July 1, 2024, Medical Devices and IVDs in Great Britain (England, Wales, and Scotland) can be marked with either CE or UKCA marking (or both).
MHRA (Medicines and Healthcare products Regulatory Agency)
To submit for UKCA marking, manufacturers must first register with the MHRA. The MHRA is responsible for regulating the UK Medical Devices market. The MHRA’s goal is to enact legislation during Spring 2023 that focuses on post-market surveillance, in order to emphasize the high priority placed on patient safety.
UK Approved Bodies
The MHRA is responsible for the designation and monitoring of UK Approved Bodies (UKABs) and have acknowledged concerns with access to UKABs. There are currently four designated UKAB’s, with an additional potential six who have already applied. There are several other agencies with interest in becoming UKABs, in which the twelve-month extension allows for the number of Approved Bodies to increase. UKABs can conduct conformity assessments in relation to the UKCA marking for Medical Devices and Active Implantable Devices under Part II, III, and IV of the UK MDR 2002. It is important to note that the EU no longer recognizes UKABs, therefore UKAB’s cannot issue CE certifications.
Appointing a UK Responsible Person
Manufacturers outside of the UK must appoint a UK Responsible Person (UKRP). Functionality of the role is very similar to an EU Authorized Representative. The UKRP acts on behalf the non-UK manufacturer to carry out specified tasks in relation to the manufacturer’s obligation. The UKRP must also ensure the Declaration of Conformity and Technical Documentation have been properly drawn up, and must obtain a copy for their records pending any review from the MHRA. Importers and distributors are not required to appoint a UKRP, and their name and address do not need to be present on the label, unless they are acting as the UKRP.
How to Capitalize on the UKCA Mark Delay
For now, if your Medical Device conforms to UK MDR 2022, EU MDR, or EU IVDR, and you are registered with MHRA, you are ready to enter the UK Market. However, once the clock strikes midnight on July 1, 2024, ensure that your Technical Documentation complies with UK MDR 2022, that you have appointed a UKRP, and worked with a UKAB, if applicable. Here are the immediate actions to take to ensure that you are prepared:
Step 1: Verify whether or not your product needs UKCA marking
Step 2: Check the appropriate route for conformity assessment (self-declared or third-party conformity assessment).
Step 3: Draft technical file and ensure compliance
Step 4: Draw up draft UK Declaration of Conformity
Step 5: Affix the UKCA marking and prepare to place your goods on the market
For mandatory third-party conformity assessment (UKABs):
Step 6: Identify an appropriate conformity assessment body
Step 7: Draft technical documentation
Step 8: Draw up a draft Declaration of Conformity
Step 9: Affix the UKCA marking, and prepare to place your goods on the market
While a one-year extension offers some breathing room for medical device manufacturers, now is a better time than ever to begin thinking about and planning for UKCA marking. Rook Quality Systems is here to help guide you at any step in the process. Look to Rook to help ensure compliance with these new medical device regulations for entry and success in Great Britain.