Ever since the United Kingdom (UK) left the European Union (EU), there have been lingering questions among medical device manufacturers about how the new UK regulatory and registration scheme would compare to the EU rules they replace. Recently we wrote an article with an overview of the UK medical device registration process so we won’t cover that here but we are going to cover a related issue: how and when to apply the UKCA Mark (England, Scotland and Wales) and the UKNI Mark (Northern Ireland). Let’s get to it.
First a quick geography refresher:
United Kingdom = England + Wales + Scotland + Northern Ireland
Great Britain = England + Wales + Scotland
Northern Ireland – although part of the United Kingdom – has special rules. Also, Northern Ireland is NOT a northern province of Ireland, an EU member state. We’ll discuss more in a bit.
The UK MDR is not the same as the EU MDR
It’s important to note that the UK never adopted the new EU regulations (MDR or IVDR) as national law so the UK Medical Device Regulation (UK MDR 2002) is based on the old European directives.
Medical Devices Directive (93/42/EEC)
In Vitro Diagnostic Devices Directive (98/79/EC)
Active Implantable Medical Devices Directive (90/385/EEC)
Introducing the UKCA and UKNI Mark
The UKCA Mark and UKNI Mark are the UK’s version of the CE Mark. The UKCA Mark (United Kingdom Conformity Assessed) came into existence on January 1, 2021 after Brexit occurred. Despite the all-encompassing name, the UKCA Mark is required for medical devices and IVDs sold in England, Scotland, Wales (Great Britain) but not Northern Ireland, which will continue to use CE Marking and their own UKNI Mark. Read why here.
Devices sold after July 1, 2023 in...
Great Britain (England, Scotland, Wales) must bear the UKCA Mark
Northern Ireland must bear the CE* and UKNI* Mark
* If you are selling in Northern Ireland under an EU Notified Body certificate, only CE Marking is required. If you are selling there under a UK Conformity Body certificate, UKNI and CE Marking is required on labeling. The UKCA Mark is not recognized in Northern Ireland.
UKCA and UKNI Mark symbols
Here are some basic requirements for using the UKCA and UKNI symbols.
The mark must be clearly visible and legible, affixed to the product.
If that's not practical, you must attach it to the packaging or accompanying documents, such as your Declaration of Conformity or Instructions for Use (IFU)
The UKCA and UKNI marking must be at least 5mm in height
UKCA Mark used in England, Scotland and Wales (Great Britain)
UKNI Mark used in Northern Ireland only
What needs to be included on your UK Declaration of Conformity?
The information below that must be added to your UK MDR Declaration of Conformity (DOC) as shown below.
Your company name and business address (if located in UK) or your UK Responsible Person (UKRP)
Device serial number, model or type ID
List relevant UK legislation: Medical Devices Regulations 2002 (SI 2002 No 618, as amended - UK MDR 2002)
Listing of relevant UK standards
Details of the UK Conformity Body that carried out the assessment, if applicable
Statement that you take responsibility for the compliance with applicable regulations
Date the declaration was issued
Your name and signature
Are the UKRP and Importer symbols required on labeling?
That’s depends. Unlike the European Union which allows the use of harmonized symbols for the EC REP (Authorized Representative) and Importer in lieu of translation, the MHRA does not (yet) have a symbol to identify your UK Responsible Person or Importer. If you are selling in Great Britain via compliance with EU regulations, you do NOT need to identify your UKRP on labeling, packaging or IFU. If you are selling in Great Britain under UK under compliance with UK legislation, you DO indeed need to list your UKRP along with the number of your UK Assessment Body. In both situations you are not required to list your UK importer. Finally, the UK MHRA does not use the new EUDAMED database so no Single Registration Number (SRN) is applicable for UK labeling.
CE Marking works for now but…
The UK MHRA recognizes that companies will need time to make the transition, and they have allowing medical devices and IVDs with valid CE Marking certificates to be sold until June 30, 2023. However, you must still register your device or IVD with the MHRA. In addition, in order to apply the UKCA and UKNI mark, you must be audited by a UK Market Conformity Assessment Body (UKMCAB) – namely BSI UK, SGS UK or UL UK. Regardless of whether you are relying on CE Marking or applying the new UKCA marking, manufacturers outside the UK must appoint a UK Responsible Person and UK importer and you must do this now.
Finally, it’s important to know that the UK will eventually move over to a legislative framework that is mostly aligned with the EU MDR and IVDR. This will be implemented via the Medicines and Medical Devices Act and the MHRA is currently evaluating feedback they received between September and November 2021.