MHRA Issues Warning on False Compliance Certifications

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has cautioned devicemakers about certificates being issued by certification bodies that have no legal standing under the UK’s medical device regulations.

The certificates, titled “certificates of compliance” or “attestation of compliance,” state that the organization issuing the certificate has either reviewed the technical documentation for Class I medical devices or that the devices meet with the requirements of the EU’s 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,” the MHRA warned.