Legal requirements for manufacturer placing medical devices on the market

Medical Device CE Marking

As a manufacturer of medical devices it is required to demonstrate that your medical device meets the requirements in the Medical Devices Directive (MDD) by carrying out a conformity assessment. The conformity assessment route depends on the classification of the device.

The classification of the device in the appropriate class is the first critical activity that a manufacturer needs to complete to identify the device category and applicable rule as outlined in the MDD. The legal manufacturer will have to pass the conformity assessment based on the classification of their device, before being able to place a CE mark on their product to show that the medical device has met the essential requirements.

Assessment Routes

Class I Devices

If the legal manufacturer is satisfied that the medical device complies with the requirements in the MDD, they must write a statement to declare this. For medical devices that are sterile products or have a measuring function, they are required to apply to a notified body to approve and certify the parts of your manufacturing process that relates to sterility or metrology.

It is required that you register your device(s) with the relevant competent authority. The legal manufacturer can place a CE mark on the product and place it on the market when you have done this.

Class IIa Devices

The legal manufacturer needs 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)

The legal manufacturer can place a CE mark on your product and place it on the market when you have received a certificate from the notified body.

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

The legal manufacturer 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

The legal manufacturer can place the CE mark on the product and place it on the market when you have received certification from the notified body.

Compliance with harmonised standards

The legal manufacturer has 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

The legal manufacturer may need to carry out a clinical investigation to demonstrate that your medical device complies with the MDD.

CE Marking

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 Union.
The legal manufacturer must sign a ‘declaration of conformity’ before placing the CE mark on your product. 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
The legal manufacturer 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