Impact on Medical Devices Market
UKCA Mark
The UKCA Mark stands for United Kingdom Conformity Assessment (UKCA) Mark. This is a new product marking adopted by the UK and is applicable for goods being placed in Great Britain. The UKCA marking requirement is for most of the goods that are subjected to CE Marking, prior to Brexit. Medical Devices require UKCA certification and are also subject to some special rules.
Conformity Assessment Bodies
From 1st January 2021, Class I medical device and general IVD manufacturers can carry out self-declaration for their conformity to EU MDD or EU IVDD; affix the UKCA mark and launch the device in Great Britain by following the UKCA mark guidelines and UKCA mark guidance.
The devices shall comply with applicable annexes to Directive 90/385/EEC on Active Implantable Medical Devices (EU AIMDD), Directive 93/42/EEC on Medical Devices (EU MDD) and Directive 98/79/EC on In Vitro Diagnostic Medical Devices (EU IVDD), to seek the UKCA marking.
Once the UKCA Marking is successfully obtained from the UK Conformity Assessment bodies, the manufacturer and UK Responsible Person (UKRP) shall ensure that the device technical file and UK Declaration of Conformity are up-to-date and should be readily available for submission, whenever requested by the Market Surveillance Authority.
CE marking
A CE marking (abbreviated from the French - ‘Conformité Européene’) is a mandatory certification mark on many products placed on the single market in the European Economic Area (EEA) that indicates conformity, consumer safety, health or environmental requirements standards for products sold within the European Economic Area.
The UK CE mark ensures that the medical device is meeting all the EU safety, health and environmental requirements. The UK CE mark medical device ensures that it is compliant with the EU legislation. The UK CE mark helps in free movement of the product within the European market. The CE marking on the product declares that the manufacturer has met all the CE marking requirements to achieve the UK CE mark. The manufacturer hence validates the product to be sold in the European market. The CE marking does not assure that the product was manufactured or developed in the EEA. But it indicates that the product was assessed before placing on the market.
Notified Bodies
The current UK based Notified Bodies for the purpose of UKCA marking are required to be designated as UK Approved Bodies. The new bodies have to undergo a detailed approval process to be designated for carrying out the UKCA conformity assessments. A new database is being set up by the UK Government to include the list of the UK Approved Bodies, which is expected to play a similar role as the EU’s NANDO (New Approach Notified and Designated Organizations) Information System.
Labelling requirements
From 1st January 2021, the medical device label to be placed in Great Britain should include:
- The UKCA mark or a CE marking, depending on which legislation the device has been certified under
- The number of the Notified Body or Approved Body where applicable
- The devices with a valid CE marking do not need the UKCA mark until 1st July 2024
- Devices can have both the UKCA and CE marks affixed till 1st July 2024 and the dual marking will be accepted after 1st July 2024
- The devices with UKCA mark (including dual labelled) affixed on their labels shall include the UKRP details
UKNI marking
UKNI marking stands for the United Kingdom Northern Ireland marking commonly known as UKNI mark, which is a new conformity marking to be used on various goods, including the medical devices that are being placed in the Northern Ireland market. This is also represented as the UK(NI) mark or the UK(NI) indication.
