UKCA marking for medical devices-Operon Strategist

UKCA stands for United Kingdom Conformity Assessed, and is applied to products placed on the market in the UK. This replaces the CE mark, which – pending changes to legislation - is recognised in the UK until the 30th June 2023. So from this date onwards, medical device manufacturers need to comply with the new UKCA marking regulations.

manufacturers now need to plan for how they will obtain a UK Conformity Assessment mark before 30th June 2023. As many have seen, there have been delays in obtaining the mark, so the quicker manufacturers act, the better.

Operon strategist is medical devices consultinghas a good experience in consultation and regulatory expertise for manufacturers and suppliers of medical devices. for any medical device registration process, UKCA marking and licensing you can connect with us.

WHAT ARE THE REQUIREMENTS FOR CE MARKED PRODUCTS IN THE UK?

From 1 January 2021, there are a number of requirements that products marketed as medical devices in Great Britain (England, Wales and Scotland) must comply with:

Certificates issued by notified bodies recognised by the EU will remain valid for the UK market until 30 June 2023.

The EU no longer recognises the UK’s notified bodies.

UK Notified Bodies cannot issue CE certificates (except for the purposes of the "CE UKNI" mark, which is valid in Northern Ireland), and have become UK Approved Bodies.

A new route to market and product marking is available for manufacturers wishing to obtain UKCA marking for medical devices.

From 1 January 2021, all medical devices, including in vitro diagnostic (IVD) medical devices, marketed in Great Britain must be registered with the MHRA. There is a grace period for registration:

• Class III and Class IIb implantables, and all active implantable medical devices and IVD List A products must be registered by 1 May 2021.

• Other Class IIb devices and all Class IIa devices and Schedule B IVD products and self-testing IVDs must be registered from 1 September 2021.

• Class I devices, custom-made devices and general IVDs must be registered from 1 January 2022

• Class I devices, custom-made devices and general IVDs that, prior to 1 January 2021, were required to register their devices with the MHRA (i.e. UK-based manufacturers or third country manufacturers with authorised representatives based in Northern Ireland) must continue to register their devices from 1 January 2021.

So what is the difference between what you have to do to place a CE Mark on a product versus a UKCA Mark?

There are two levels to this answer:

• The mechanics of UKCA-marking

• The regulatory basis for conformity assessment

The mechanics are that a UK Approved Body will need to perform the conformity assessments that formerly the EU Notified Body (NB) would do. It appears that the two UK-based NBs that are able to do the necessary for medical imaging products will become UK Approved Bodies automatically, so not much change there, except that they will need to authorise both a CE mark and (in due course) a UKCA mark (likely at an extra fee). It is not clear whether EU-based Notified Bodies will be allowed, and at what point in time, register as UK Approved Bodies.

Additionally, while the UK standards will be the same in substance and with the same reference as the standards used in the EU, they will use the prefix ‘BS’ to indicate that they are standards adopted by the British Standards Institution as the UK’s national standards body. All references to standards in any regulatory documentation to be submitted for a UKCA assessment would therefore have to be updated with the ‘BS’ prefix.

For Class I & general IVD:

Class I device or general IVD do not third-party conformity assessment. Class, I device manufacturers must self-declare that the device meets the UK MDR criteria. If a class I device has any sterile or measuring functions, the manufacturer needs to approach the UK-approved body for the conformity assessment.

For Class IIa, Class IIb, Class III, IVD:

For Class IIa, Class IIb, Class III, IVD medical devices involvement of a UK-approved body is necessary to undergo a conformity assessment procedure. After approval from a UK-approved body, a manufacturer can declare that devices conform with the UK MDR 2002 and place it on the market.

All class medical device manufacturers must sign a ‘declaration of conformity before placing the UKCA marking on their product. The manufacturer needs to include the name of the UK-approved body if it is involved.

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