CE vs. UKCA: How they Apply to Medical Devices
For manufacturers, importers, and distributors of medical devices, understanding the difference between CE and UKCA markings is vital. These marks signify compliance with specific standards and ensure the safety and efficacy of medical products in their respective markets.
What is CE Marking?
The CE marking, standing for "Conformité Européenne,” is a mandatory conformity mark for a wide range of products sold within the European Economic Area (EEA), which includes the 27 EU member states plus Iceland, Liechtenstein, and Norway. The CE mark demonstrates adherence to stringent EU regulations outlined in directives and regulations like the Medical Devices Regulation (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR).
What is UKCA Marking?
Post-Brexit, the UK introduced the UKCA (UK Conformity Assessed) marking to replace the CE marking for products sold in Great Britain (England, Scotland, and Wales). The UKCA mark ensures that medical devices comply with UK regulations, primarily the UK Medical Devices Regulations 2002 (UK MDR 2002).
Transition Period: Although officially in effect since January 1, 2021, the UK allowed a grace period for manufacturers to adapt. More specifically, legislation now enables CE marked medical devices to be placed on the Great Britain market to the following timelines:
general medical devices compliant with the EU medical devices directive (EU MDD) or EU active implantable medical devices directive (EU AIMDD) with a valid declaration and CE marking can be placed on the Great Britain market up until the sooner of the expiry of the certificate or 30 June 2028
in vitro diagnostic medical devices (IVDs) compliant with the EU in vitro diagnostic medical devices directive (EU IVDD) can be placed on the Great Britain market up until the sooner of the expiry of the certificate or 30 June 2030, and
general medical devices, including custom-made devices, compliant with the EU medical devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR) can be placed on the Great Britain market up until 30 June 2030.
Alignment with EU Regulations: While the UKCA marking system mirrors the EU's CE marking in many aspects, including risk classification and conformity assessment procedures, the UK now has the autonomy to diverge from EU rules in the future. CE marking remains valid for products placed on the UK market until December 31, 2024.
UK Approved Bodies: UK-based Approved Bodies take on the role of Notified Bodies, conducting conformity assessments for higher-risk medical devices. The conformity assessment procedures (testing, certification, etc.) may differ between the two markings, although there is a significant overlap currently.
The UK Government website clarifies the position regarding Northern Ireland. There the CE marking continues to be used to show that goods meet EU rules. The UKCA marking cannot be used for goods placed on the Northern Ireland market. If a UK body is used for mandatory third-party conformity assessment, the UKNI marking must be applied alongside the CE marking (CE+UKNI). The UKNI marking is not recognised on the EU market, so goods intended for the EU must use the CE marking alone.
When and How They Apply
Product Scope: Both markings cover a broad range of products, including machinery, electrical equipment, toys, medical devices, and construction products. It is essential to check the specific regulations for your product category.
Manufacturer's Responsibility: It is the manufacturer's responsibility to ensure the product complies with the relevant standards and affix the appropriate marking.
Importer/Distributor's Role: Importers and distributors must ensure products bear the correct marking and that the necessary technical documentation is available.
Enforcement: Market surveillance authorities in the EEA and the UK monitor compliance and can act against non-compliant products.
Medical Device Classification: Understanding Risk Levels
The risk categorization for medical devices under both the CE and UKCA markings is primarily based on the potential risks associated with their use. These categories determine the level of scrutiny and conformity assessment procedures required before a device can be marketed. Both systems follow the same classification rules, although there might be slight variations in specific requirements or interpretations.
Class I: These are low-risk devices, such as non-invasive medical devices or simple bandages. They undergo self-certification by the manufacturer, meaning the manufacturer declares conformity with the applicable regulations without the involvement of a third-party conformity assessment body (also known as a Notified Body under the CE marking system or an Approved Body under the UKCA marking system).
Class IIa: These are moderate-risk devices, such as contact lenses or hearing aids. These devices require a conformity assessment involving a Notified Body (CE) or an Approved Body (UKCA) to ensure they meet the essential requirements for safety and performance.
Class IIb: These are also moderate-risk devices, but with a higher potential risk than Class IIa devices, such as X-ray machines or infusion pumps. The conformity assessment for these devices involves a more rigorous review by a Notified Body (CE) or an Approved Body (UKCA) compared to Class IIa devices.
Class III: These are high-risk devices, such as implantable devices or life-supporting devices. These devices undergo the most stringent conformity assessment procedures, including a thorough examination of the device's design, manufacturing processes, and clinical data by a Notified Body (CE) or an Approved Body (UKCA).
Understanding the CE and UKCA markings is vital for businesses involved in manufacturing, importing, or distributing products within the EEA or the UK. Product compliance is an ongoing process. Regulations and standards can and will evolve so staying informed is essential for manufacturers and importers.
At Taylored Consultancy we specialise in providing expert regulatory affairs consulting services to medical device manufacturers and distributors across the UK and EU. We’d love to hear from you with your questions about UKCA and CE conformity.
