Posted by Priscilla Soerachmat, September 25, 2023
Regulation Updates: UKCA vs CE Markings for Medical Devices
Within the EU, CE marking is mandatory for machinery, electrical and electronic equipment, medical devices, personal protective equipment and toys. As such, anyone looking to sell electrical products in the EU will need to test for compliance and affix a CE mark to their product.
Previously, these standards were uniform across all European Union members, including the United Kingdom. However, this changed due to Brexit.
CE Marking Timeline Extensions
UKCA marking replaced CE marking on 1 January 2021. Therefore, most products that previously required CE markings would need to have a UKCA mark in order to be sold on the UK market.
However, as of August 1st, 2023, in order to give businesses time to adjust, the UK government updated their plan to grant an ongoing recognition of the CE marking for the distribution of a wide range of goods within Great Britain, extending indefinitely beyond December 2024.
The utilization of the UKCA marking is mandatory for individuals or entities involved in the production or handling of products within the subsequent sectors:
|Toys||Measuring instruments||Gas appliances|
|Pyrotechnics||Measuring container bottles||Machinery|
|Recreational craft and personal watercraft||Lifts||Equipment for use outdoors|
|Simple pressure vessels||Equipment for potentially explosive atmospheres (UKEX)||Aerosols|
|Electromagnetic compatibility||Radio equipment||Low voltage electrical equipment|
|Non-automatic weighing instruments||Personal protective equipment (PPE)||Pressure equipment|
For Medical Devices, the current rules is also to accept CE marking, but with a different timeline.
Regulating Medical Devices in the UK
(updated July 27th, 2023)
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market.
Some CE marked devices will be accepted in the Great Britain market until 30 June 2030 depending on device type and classification (see below): (Source: www.gov.uk)
- Implementation of Future Regulations
The UK government is embarking on a journey to implement substantial reforms in the existing regulatory framework for medical devices. The blueprint for this reform was outlined in response to the 2021 consultation on the future regulation of medical devices in the UK. The primary goal is to introduce a phased approach that ensures a proportionate implementation of the future regulatory framework. This approach is designed to bolster system readiness and minimize the risk of supply disruptions for patients in the UK.
NOTE: The United Kingdom will continue to accept EU certificates for medical devices until June 30, 2030, as per existing legislation. However, additional updates on the regulatory regime for medical devices are expected to come into effect from July 1, 2025. This suggests a transition period for the medical device regulatory landscape in the UK.
- Transitional Arrangements
To facilitate a smooth transition towards the new regulatory framework, the UK government has put in place legislation that modifies The Medical Device Regulations 2002 (SI 2002 No 618, as amended) (UK MDR). These amendments extend the acceptance of CE marked medical devices on the Great Britain market. This extension aims to support the uninterrupted supply of medical devices to Great Britain and ease the transition to the future regulatory framework.
Key timelines for the acceptance of CE marked medical devices on the Great Britain market:
Certain self-declared CE marked Class I medical devices may continue to be placed on the Great Britain market beyond June 30, 2023, under specific conditions.
For more information, please visit:
Speed up your Time to Market with Silex Technology's Certification Services
Silex certification services help you lower costs, improve lead times, and reduce risk. can help you navigate the complexities of regulatory compliance. We'll give you a step-by-step approach to getting certified. Our 20+ years of experience as a Wi-Fi module provider will help you plan for compliance considerations, so there's no delay in product certification, and you can launch on time and on budget.
Certification Testing Services
We know what it takes to meet the ETSI, FCC, and other wireless testing specifications for wireless radio manufacturers. In fact, many device manufacturers outsource their certification responsibilities to Silex because of our experience. Let us guide you through the certification process. Learn more >>
Silex Wi-Fi modules already come pre-certified and modular certified for North America, Europe, and Japan. If you need certification for additional countries and regions, we can guide you through it. Our long-term relationships with certification test labs and local reps, mean that we get priority support to achieve certification project execution on time and on budget. Learn more >>
Keeping Up with Regulatory Compliance Changes
Once regulatory certification and country registration(s) are done, it's critical to stay on top of the regulatory changes to remain compliant. Silex Technology closely monitors the ever-changing certification requirements and proactively informs customers of upcoming changes and required renewals. We also publish updates regularly on the Silex Unwired blog to keep customers informed.
Visit www.silextechnology.com for more information