To place medical devices or in vitro diagnostic (IVD) medical devices on the Great Britain (GB) market (England, Scotland and Wales), you must comply with UKCA mark regulations, including requirements from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA).
In addition, you must meet the UK Medical Device Regulations (UK MDR) 2002 requirements. The UK MDR currently mirrors the EU Medical Device Directives for medical devices and IVD devices. It applies to all medical device types, including Class I (sterile and measuring), Class IIa, Class IIb (implantable and non-implantable) and Class III devices, as well as IVD devices under List A, List B and self-test classifications.
How can SGS help?
As a UK Approved Body, we can certify your quality system and technical documentation to verify that they meet the MHRA and UK MDR 2002 requirements and are ready for UKCA marking.
We also offer:
- Training to help you understand the UKCA marking requirements
- Integrated and/or combined audit solutions that save you time and money
- Conformity assessment and certification services for specific medical device requirements
- A dedicated account management team to ensure that your certification project gets the relevant support
- Global resources and a local presence – our people speak the language, understand the local market and operate globally
Your partner for regulatory compliance
Regulatory compliance is a complex ongoing process. As a global organization, SGS is one of the few regulatory bodies that can provide medical device certification services across all of Europe, including Great Britain and Northern Ireland. Our experienced experts and specialized laboratories worldwide can support every step of your compliance journey, even for technologically sophisticated products.
We are:
- An EU Notified Body in Belgium (1639)
- An EU Notified Body in Finland (0598) for clients specifically needing Software as a Medical Device (SaMD) certification
- A UK Approved Body for the UKCA mark (0120)
- An approved Medical Device Single Audit Program (MDSAP) Auditing Organization (AO)
Accessing the EU market through Great Britain
The UKCA mark is not recognized in the EU, so you must have a CE mark to place medical devices or in vitro diagnostic medical devices on the EU market. However, given the similarities of the regulatory requirements and conformity assessment procedures for both markets, expanding your products into the EU market from Great Britain, using UK MDR 2002 as a foundation, can be straightforward.
If you have an established presence in the UK or are familiar with a previous EU Directive equivalent to the UK MDR, it can be easier to start with the UKCA mark before adding the CE mark. This phased approach gives you more time to assess demand and refine your products before entering the more diverse EU market.
You can also pursue both marks concurrently depending on your products, strategies and resources. We can help by providing a combined conformity assessment process.
Contact us today to learn more about UKCA compliance for medical devices and IVD medical devices.