UKCA marking for different product categories
Now the UK has left the EU, the timelines for accepting CE marking on the Great Britain market are coming to an end. All CE marked products must be UKCA marked by 1 January 2023, except for medical devices and IVD’s which must be UKCA marked by 1 July 2023. It is important to understand if and when UKCA marking for products that fall in multiple categories is required. This tip is about just that.
Medical devices and IVD’s that also fall in other categories
It may be confusing if a product is a medical device or IVD and also falls into another product category; which deadline would apply? In the MDR, Article 1(11) the MDR is identified as more specific than the horizontal legislation (e.g. requirements for electromagnetic compatibility are covered in MDR Annex I, the EMC Directive does not apply) and Article 1(12) specifies the Machine Directive equally applicable.
The UK has not implemented the MDR into their laws, so they need to fall back on other legislation. Articles 1(11) and 1(12) don’t tell us much news though, most of that can already be deducted from other, ‘older’, legislation. The MHRA has simply summarized that into: if two deadlines apply, apply the latest deadline. This means for example that a medical device that is also a low voltage product, may face 1 January for the Electrical Equipment (Safety) Regulations and 1 July for the Medical Devices Regulations. In that case there is only one UKCA marking required and it has to be applied from (for now) 1 July 2023.
The 1 January 2023 deadline applies for all products for which also CE-marking applies, plus aerosol products that previously required the ‘reverse epsilon’ marking. Listed below are the product categories that require UKCA marking according to gov.uk guidance, plus their UK equivalent legislation. Products that may require UK Approved Body certification for at least one group of these products are marked with an asterisk:
- Toy safety* – Toys (Safety0 Regulations 2011
- Pyrotechnics* – (no UK legislation provided)
- Recreational craft and personal watercraft* – Recreational Craft Regulations 2017
- Simple pressure vessels* – Simple Pressure Vessels (Safety) Regulations 2016
- Electromagnetic compatibility* – Electromagnetic Compatibility Regulations 2016
- Non-automatic weighing instruments* – Non-automatic Weighing Instruments Regulations 2016
- Measuring instruments* – Measuring Instruments Regulations 2016
- Lifts* – Lifts Regulations 2016
- ATEX* – Equipment and Protective Systems Intended for use in Potentially Explosive Atmospheres Regulations 2016
- Radio equipment* – Radio Equipment Regulations 2017
- Pressure equipment* – Pressure Equipment (Safety) Regulations 2016
- Personal protective equipment* – Regulation 2016/425 on personal protective equipment as brought into UK law and amended
- Machinery* – Supply of Machinery (Safety) Regulations 2008
- Equipment for use outdoors* – Noise Emission in the Environment by Equipment for use Outdoors Regulations 2001
- Ecodesign – See Schedule 1 to The Ecodesign for Energy-related Products Regulations 2010 (as amended) for the applicable implementing measures which apply in Great Britain and Northern Ireland, respectively
- Aerosols – (no UK legislation provided)
- Low voltage electrical equipment – Electrical Equipment (Safety) Regulations 2016
- Restriction of hazardous substances – The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012
Products covered by the UKCA marking that have some special rules:
- Medical devices*– (no UK legislation provided)
- Rail interoperability*– (no UK legislation provided)
- Construction products*– (no UK legislation provided)
- civil explosives*– (no UK legislation provided)
Not on the above list and for which it is assumed UKCA marking and UKAB certification is required:
- Hot water boilers (Directive 92/42/EEC)
- Marine equipment (Directive 2014/90/EU)
- Unmanned aircraft systems (Regulation (EU) 2019/945)
- Cableway installations (Regulation (EU) 2016/424)
- IVD’s (Regulation (EU) 201/746)
Planning UKCA marking
For medical devices and IVD’s the requirements have not been published, so it is not possible to make detailed plans. How to go about with that is next week’s tip. But in the meanwhile you can already plan for any UKCA marking of products from other categories:
- Carefully analyze the full portfolio of products that are placed on the UK market on your behalf, including the content of procedure packs and systems. Also carefully consider any product from other manufacturers that is distributed, made available or used together with your devices.
- Determine all product categories that may apply for those products.
- Determine if UK Approved Body certification is necessary.
- For product for which you are the manufacturer: search and select an appropriate UK Approved Body and ensure a place in the queue for certification.
- For products that are manufactured by someone else: verify if they are on top of their UKCA marking, if not, look for alternatives.
- And obviously, last but not least: make sure that are meeting all formalities regarding labeling, economic operators, registration etc. that are related to the relevant requirements.
