Certificates of Compliance or Attestation of Conformity have no legal standing under UK Medical Device Regulations 2002

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has reported that Certificates of compliance or Attestation of Conformity documents have no legal standing under the UK Medical Device Regulations 2002.

According to the agency, these certificates state that the organisation issuing the certificate has either reviewed the technical documentation for Class I medical devices, or that the devices concerned meet with the requirements of the Medical Device Directive 93/42/EEC. They are not evidence that the manufacturer has met the regulatory requirements of the UK Medical Device Regulations 2002, nor are they CE Certificates issued under Directive 93/42/EEC.

Evidence of registration and declaration of conformity are documents of regulatory validity and may be requested from the manufacturer or the EU Authorised Representative.

For Class I medical devices, the manufacturer of the medical device must issue a Declaration of Conformity to Directive 93/42/EEC and must register their Class I medical device with an EU Competent Authority for medical devices. For non-EU manufacturers, an EU-based Authorised Representative must be appointed and will undertake the registration on their behalf. There is no CE Certificate for a Class I medical device unless that device is supplied sterile or has a measuring function.

Information on the requirements for Class I medical devices may be found here

In addition, all Class I medical devices which are supplied sterile or have a measuring function and all other classes of medical devices must obtain a CE certificate from a Notified Body designated under the Medical Device Directive.