Medical Device “Certificates of Compliance” / “Attestation of Conformity” have no legal standing under UK Medical Device Regulations 2002
The MHRA is aware of certificates being issued by certification bodies headed “certificates of compliance” or “Attestation of Compliance”.
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.
These certificates are not evidence that the manufacturer has met the regulatory requirements, and should not be taken as proof of such.
Certificates of compliance or Attestation of Conformity documents have no legal standing under the UK Medical Device Regulations 2002. They are not evidence that the manufacturer of the device has met the requirements of the UK Medical Device Regulations 2002, nor are they CE Certificates issued under Directive 93/42/EEC.
The certification body may have issued the certificate or attestation following a review of the technical documentation for the medical device concerned. However, this is not a regulatory requirement and so the certificate issued has no regulatory validity.
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
For Class I medical devices which are supplied sterile or have a measuring function and for all other Classes of medical devices the manufacturer must obtain a CE certificate from a Notified Body designated under the Medical Device Directive. This must be done in addition to the registration and declaration of conformity. A list of designated Notified Bodies is available on the European Commission website.
Valid CE certificates will be issued by one of the organisations listed and will have been issued from within the EU.
If you have any questions relating to this matter please contact info@mhra.gov.uk.