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. Specially, how and when the UKCA and UKNI marks should be applied. 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:
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United Kingdom = England + Wales + Scotland + Northern Ireland
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Great Britain = England + Wales + Scotland
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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.
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Medical Devices Directive (93/42/EEC)
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In Vitro Diagnostic Devices Directive (98/79/EC)
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Active Implantable Medical Devices Directive (90/385/EEC)
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Introducing the UKCA and UKNI Mark
The UKCA and UKNI Marks 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.
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Updates from June 2023:
The UK government has made changes to the UK MDR (2002) to extend the acceptance of CE marked medical devices on the Great Britain market. Those amendments will enter into force on 30 June 2023. (full legal text: The Medical Devices (Amendment) (Great Britain) Regulations 2023 (legislation.gov.uk)).
Under the new amendments, the timelines for placing CE marked medical devices on the Great Britain market are as follows:
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- Medical devices compliant to the EU MDD or EU AIMDD can be placed on the market until the earlier of the certificate’s expiry or 30 June 2028.
- IVDs compliant with the EU IVDD can be placed on the market until the earlier of the certificate’s expiry or 30 June 2030.
- General medical devices, including custom-made devices, compliant with the EU MDR, and IVDs compliant with the EU IVDR can be placed on the market until 30 June 2030.
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Here are some basic requirements for using the UKCA and UKNI marks.
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The mark must be clearly visible and legible, affixed to the product.
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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)
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The UKCA and UKNI marking must be at least 5mm in height
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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.
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Your company name and business address (if located in UK) or your UK Responsible Person (UKRP)
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Device serial number, model or type ID
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List relevant UK legislation: Medical Devices Regulations 2002 (SI 2002 No 618, as amended – UK MDR 2002)
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Listing of relevant UK standards
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Details of the UK Conformity Body that carried out the assessment, if applicable
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Statement that you take responsibility for the compliance with applicable regulations
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Date the declaration was issued
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Your name and signature
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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 marks, 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.