Medicines, medical devices and blood regulation and safety – guidance

Medical devices: conformity assessment and the CE mark

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

You need to demonstrate that your medical device meets the requirements in the Medical Devices Directive (MDD) by carrying out a conformity assessment. The assessment route depends on the classification of the device.

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

Assessment routes

Class I devices

If you are satisfied that your medical device complies with the requirements in the MDD, you must write a statement to declare this. You need to apply to a notified body 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.

Register your device(s) with the relevant competent authority if you haven’t already done so. This is MHRA in the UK.

You can place a CE 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 the MDD as well as the Medical Devices Regulations 2002. You also need to apply to a notified 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 (Annex IV of the MDD)
  2. audit of the production quality assurance system (Annex V of the MDD)
  3. audit of final inspection and testing (Annex VI of the MDD)
  4. audit of the full quality assurance system (Annex II of the MDD)

You can place a CE mark on your product and place it on the market when you have received a certificate.

Class IIb devices

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

  • an annex II audit of full quality assurance system or;
  • an annex III type-examination plus either option 1,2 or 3 given for the class IIa devices above

You can place a CE mark on the product and place the product on the market when you have received a certificate from the notified body.

Class III devices

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

  • an annex II audit of the full quality assurance system including a design dossier examination or;
  • an annex III type-examination plus 1 of the option 1,2 or 3 given for the class IIa devices above

You can place the CE mark on the product and place it on the market when you have received certification from the notified body,

More information

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

Compliance with harmonised standards

You have the option to use any international standard that has been harmonised to the medical device directives. If you comply with these harmonised 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 these standards is not mandatory, however most manufacturers choose to use them.

The European Commission lists these harmonised standards for: medical devices, active implantable medical devices and in vitro diagnostic medical devices.

Clinical investigations

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

The CE marking

A CE mark is a logo that is placed on medical devices to show they conform to the requirements in the directives. 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 anywhere in the European Unionl.

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

The CE marking also means that the product can be freely marketed anywhere in the EU (27 member states of the EU and EFTA countries, Iceland, Norway and Liechtenstein). The mark does not indicate the origin of the product. You are not required to comply with any national schemes when exporting these devices to other countries. CE marked medical devices are subject to inspection by the market surveillance authorities of the relevant member states.

An identification number for a notified body needs to be placed below the CE mark if it has been involved in the conformity assessment.

Exemptions

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

  • a custom-made device – although it must still meet the requirements in the directives 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.

The European Commission’s website has more information on CE marking.