Introduction:
Companies that manufacture medical devices and sell products in the UK must now make strategies for how they will get a UK Conformity Assessment. The CE mark, which has been required by EU law since 1985 for medical devices supplied in the UK, may continue to be visible. The UKCA mark will be in effect from July 1,2024 and will allow medtech manufacturers two more years to comply. This does not, however, guarantee that all device manufacturers will be ready by that time. Up to June 30, 2023, medical devices with the CE mark will be available on the market. However, after that date, all medical devices and IVDs must have the UKCA certification in order to be sold.
There are few exceptions for the Northern Ireland manufacturers, and we have discussed those in our previous blogs as well. You can visit those articles for more information.
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In order to be in market after the 2023 deadline manufacturers need to take some actions or we can say that they need to plan strategically. let’s take a look :
How Can Medical Device Manufacturers Comply With UKCA Certification?
The very first step is that medical device manufacturers should register their medical device or IVDs with MHRA (UK Medicine and healthcare product Regulatory Agency). MHRA functions similarly to EU notified Bodies, they conduct assessment for the relevant requirements to grant UKCA. As per the UK medical device regulation 2002, devices are classified in four classes based on the intended purpose of device. The classes are:
- Class I are low-risk devices
- Class IIa are medium-risk devices
- Class IIb are slightly more complex devices
- Class III are high-risk devices
remain valid until 31st December 2024 MHRA presented registration Guidelines for certain classes of devices .so to get UKCA certification manufacturers need to follow the set guidelines and registration dates and in case of any ambiguity they can take guidance from any experienced medical device regulatory consultant.
Is There any Difference Between UKCA Marking and CE Marking?
UKCA & CE marking serve the same purpose as to leave a permission to market medical device in respective countries. UKCA technical file need to be in conformance with UK MDR 2002 which is aligned with MDD/IVDD regulations. And CE technical file need to be in conformance with MDR 2017/745
Some other gaps for both the certifications are as mentioned below:
- UK approved body issues UKCA certification whereas for CE marking it is Eu notified bodies.
- Instead of an EU Authorized Representative (EC Rep), a UK Responsible Person (UKRP) is necessary, for UKCA certification.
- Moreover there are some gaps in requirements for complying to respective regulations.
What is UKRP? Are They Needed for UKCA Compliance?
The manufacturers who are outside the UK, need to appoint UKRP( United Kingdom Responsible Person) to take responsibility on behalf of the manufacturer.They are a key point of contact in registering the device with MHRA before it get placed in the market and hence outside manufacturer needs UKRP for UKCA complince .
What Does UKCA Compliance Mean for Medical Devices?
The UKCA marks indicates that you have passed conformity assessment as per UK MDR 2002 regulations which can be used for placing medical device in UK (Great britain) that is England, Wales, and Scotland. It will not be recognised in the Northen Ireland Market.
Is It Really Necessary to Use UKCA Marking for Devices?
Devices must be UKCA marked if the manufacturer intends to sell them in the Great Britain market; however, the CE mark is also valid up to a remain valid until 31st December 2024.
Is the UKCA Marking Valid Forever or Does It Expire?
The UKCA certificate have the expiry date and after which the medical device manufacturers should apply for recertification
Who Can Help the Manufacturers to Comply With UKCA Certification for Devices?
UKCA marking for the devices requires a lot of paperwork and research. The medical device regulatory consultant assists manufacturers in creating technical file for UKCA mark, presenting their case for approval, replying to queries if any arises.Medical device regulatory consultants are familiar with the approval bodies’ methodologies, making it easier for them to successfully complete the UKCA mark procedure on time.
Expert UKCA Compliance Support from Operon Strategist's Regulatory Consultants
If you need assistance with UKCA compliance for your medical devices, Operon Strategist’s experienced medical device regulatory consultants can guide you through the process and help you meet the necessary requirements. Contact us for expert support in achieving UKCA certification. give heading for this content
