Conformity Assessment for medical device regulation is determined by the classification of the device. Classification is a ‘risk based’ system based on the vulnerability of the human body, taking account of the potential risks associated with the devices. This approach uses classification rules which are set out in Annex IX of Directive 93/42/EEC.

The classification rules are based on criteria such as duration of contact with the patient, degree of invasiveness and the part of the body affected by the use of the device. All software is considered an active medical device.

Class I: A medical device with low risk.
Class IIa: A medical device with low to medium risk.
Class IIb: A medical device with medium to high risk.
Class III: A medical device with the highest possible risk.

Depending on the classification of the device there are a number of conformity assessment routes which can be used for the regulation of the device. These are outlined in 93/42/EEC, Article 11 and documented in the associated Annexes of the medical device directive.

For class I devices (non-sterile and without measuring function), the manufacturer is responsible for ensuring that products comply with the legal requirements. The manufacturer will compile a technical file with evidence of conformity and will sign a Declaration of Conformity. A UKCA mark is applied by the manufacturer and the device is registered with MHRA.

Where a Class I medical device is sterile or has a measuring function, assessment by a UK approved body is required for the functions relating to sterility or metrology.

Evidence

Directive 93/4/EEC Preamble

‘whereas the conformity assessment procedures for Class I devices can be carried out, as a general rule, under the sole responsibility of the manufacturers in view of the low level of vulnerability associated with these products; ‘

Directive 93/4/EEC, Article 11 Conformity assessment procedures, Section 5

In the case of devices falling within Class I, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, follow the procedure referred to in Annex VII and draw up the EC declaration of conformity required before placing the device on the market.

(Annex VII – EC Declaration of Conformity)