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
devices.regulatory@mhra.gov.uk
