The Medicines and Healthcare Products Regulatory Agency (MHRA) has warned that being issued certain certifications does not qualify a product to be marketed in the UK.
The MHRA said documents known as “Certificates of Compliance” or “Attestation of Conformity” have no legal bearing under the UK’s Medical Devices Regulations or the EU’s Medical Devices Directive (soon to be superseded by the EU Medical Devices Regulation):
“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.”
It is recommended that any organisation currently relying on these documents for their marketing authorisation should immediately review their options and obtain a full CE mark.
Read the MHRA article for more information.