Guidance

Medical devices: conformity assessment and the UKCA mark

How to conform with the legal requirements for placing medical devices on the market.

Overview

This guidance outlines the conformity assessment process for medical devices, and how you can apply a marking to your device.

This guidance is divided into sections on the different rules that apply in Great Britain and Northern Ireland. Great Britain is England, Wales and Scotland.

For Northern Ireland, different rules apply to those in Great Britain. For more information on conformity assessments and marking of your device for purposes of the Northern Ireland market, please see the section on Northern Ireland below.

Assessment routes

The UKCA mark is a product marking which can be used for medical devices placed on the Great Britain (England, Wales, Scotland) market. The UKCA mark will not be recognised on the Northern Ireland market. A CE mark or CE UKNI mark will be needed for devices placed on the Northern Ireland market.

UKCA mark requirements for medical devices are based on the 3 main types of medical devices and their associated Part in the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002):

  • general medical devices: Part II of the UK MDR 2002
  • active implantable medical devices: Part III of the UK MDR 2002
  • in vitro diagnostic medical devices (IVDs): Part IV of the UK MDR 2002

You need to demonstrate that your medical device meets the requirements in the UK MDR 2002 by carrying out a conformity assessment. The assessment route depends on the classification of the device.

You can place a UKCA mark on your product to show that the medical device has met the requirements when you have passed the conformity assessment.

Class I devices

If you are satisfied that your medical device complies with the requirements in the UK MDR 2002, you must write a statement to declare this. You need to apply to an Approved Body (located within the UK) to approve and certify the parts of your manufacturing process that relates to sterility or metrology, if your medical device includes sterile products or a measuring function.

See guidance on Class I medical devices for more information.

You can place a UKCA mark on the product and place it on the market when you have done this.

Class IIa devices

You need to declare that your Class IIa device conforms to the requirements in UK MDR 2002. You also need to apply to an Approved Body to carry out a conformity assessment to approve your declaration.

The type of assessment you choose can be either an:

  1. examination and testing of each product or homogenous batch of products (Part II of the UK MDR 2002, Annex IV (as modified by Part II of Schedule 2A to the UK MDR 2002)
  2. audit of the production quality assurance system (Part II of the UK MDR 2002, Annex V (as modified by Part II of Schedule 2A to the UK MDR 2002))
  3. audit of final inspection and testing (Part II of the UK MDR 2002, Annex VI (as modified by Part II of Schedule 2A to the UK MDR 2002))
  4. audit of the full quality assurance system (Part II of the UK MDR 2002, Annex II (as modified by Part II of Schedule 2A to the UK MDR 2002))

You can place a UKCA mark on your product and place it on the market when you have received a certificate from the Approved Body.

Class IIb devices

If your device falls into this category you must carry out either:

  • a Part II of the UK MDR 2002, Annex II (as modified by Part II of Schedule 2A to the UK MDR 2002) audit of full quality assurance system or;
  • a Part II of the UK MDR 2002, Annex III (as modified by Part II of Schedule 2A to the UK MDR 2002) type-examination plus either option 1, 2 or 3 given for the Class IIa devices above

You can place a UKCA mark on your product and place it on the market when you have received a certificate from the Approved Body.

Class III devices

If your device falls into this category you must carry out either:

  • a Part II of the UK MDR 2002, Annex II (as modified by Part II of Schedule 2A to the UK MDR 2002) audit of the full quality assurance system including a design dossier examination or;
  • a Part II of the UK MDR 2002, Annex III (as modified by Part II of Schedule 2A to the UK MDR 2002) type-examination plus 1 of the option 1, 2 or 3 given for the Class IIa devices above

You can place a UKCA mark on your product and place it on the market when you have received a certificate from the Approved Body.

In vitro diagnostic medical devices

You can read more about assessment routes for IVDs in our separate guidance for IVDs.

More information

See flow charts (PDF, 435KB, 4 pages) that illustrate these conformity assessment routes.

For the purposes of this flow chart, read:

  • “CE marking” as “UKCA marking”
  • any reference to Competent Authority as “MHRA”
  • any reference to notified bodies as “Approved Body”

Compliance with designated standards

You have the option to use any international standard that has been designated to the UK MDR 2002, as set out in regulation 3A. If you comply with these designated standards you will conform with the relevant parts of the directive that are covered by these standards. This includes standards such as ISO 13485 covering quality management systems for medical device manufacturers and ISO 14971 covering risk management for medical devices and other process-specific standards, such as those covering sterilisation.

There are also standards which are specific to individual types of medical devices. The use of standards is not mandatory; however, most manufacturers choose to use them.

Clinical investigations

You may need to carry out a clinical investigation to demonstrate that your medical device complies with the UK MDR 2002. See how to notify MHRA of a clinical investigation for more information.

The UKCA mark

A UKCA mark is a logo that is placed on medical devices to show they conform to the requirements in the UK MDR 2002. It shows that the device is fit for its intended purpose stated and meets legislation relating to safety. It shows the product can be freely marketed in Great Britain (England, Wales and Scotland). Read more about how to use the UKCA mark.

You must sign a ‘declaration of conformity’ before you can place the UKCA mark on your product.

An identification number for an Approved Body needs to be placed below the UKCA mark if it has been involved in the conformity assessment.

Please note that devices bearing a UKCA mark cannot be placed on the market in Northern Ireland unless it is accompanied by a CE mark.

Exemptions

You should not place a UKCA mark on your medical device if it is:

  • a custom-made device – although it must still meet the requirements in the UK MDR 2002 and the type of device should be labelled clearly
  • undergoing a clinical investigation – it must include ‘exclusively for clinical investigation’ and meet the requirements as far as possible – you must take precautions to protect the health and safety of patients
  • an in vitro diagnostic medical device (IVD) for performance evaluation
  • a non-compliant device used in exceptional circumstances (humanitarian grounds)

You don’t need get these checked by a third party to show they conform with the requirements but you need to draw up a statement to declare their compliance for custom-made devices, clinical investigations and performance evaluation devices.

Northern Ireland

Although the UKCA mark will be available for use in Great Britain (England, Wales and Scotland), a CE marking will continue to be needed for devices placed on the Northern Ireland market and EU rules will need to be met. To place a CE marking on your device for circulation in both Northern Ireland and the EU, you must use an EU-recognised Notified Body to undertake any mandatory third-party conformity assessment.

If you choose to use a UK Notified Body for mandatory third-party conformity assessment for purposes of the Northern Ireland market you will need to apply the UKNI mark in addition to the CE mark. The UKNI marking is never applied on its own - it will always accompany a CE marking. Goods bearing the “CE UKNI” marking will not be accepted on the EU market. From 26 May 2021, CE mark and CE UKNI mark requirements for medical devices on the Northern Ireland market will be based on the EU Medical Devices Regulations (2017/745). Further information on compliance with the EU MDR.

Please see our guidance for further information on Northern Ireland.

Published 31 December 2020