EC Certificate (CE Marking) in accordance with Directives 90/385/EEC and 93/42/EEC is one of the approval kinds that is acknowledged by Medical Device Authority (MDA) for conformity assessment procedure by way of verification process for the purpose of medical device registration in Malaysia.

The certificate must, in principle, remain valid during the submission of a new registration or re-registration. However, due to the unclear timeline and problems associated with the transition to the EU MDR and to ensure a steady supply of medical devices on the Malaysian market, MDA has adopted a strategy to permit expired EC Certificates to be used for conformity assessment procedures by way of a verification process with the registered CABs if the following requirements are met:

• ➣The devices continue to comply with Directive 90/385/EEC and 93/42/EEC; and
• ➣There are no significant changes in the design and intended purpose; and
• ➣The devices do not present an unacceptable risk to the health or safety of patients, users, or other persons, or to other aspects of the protection of public health.

In addition, the following supporting papers must be submitted for the verification process' conformity assessment:

• ➣A formal letter from the national competent authority that has granted a derogation from the applicable conformity assessment procedure; and/or
• ➣A confirmation letter issued by the notified body stating the receipt of the manufacturer’s application for conformity assessment and the conclusion of a written agreement prior to the expiration of the certificate; and/or
• ➣An audit report as evidence that the manufacturer has put in place a quality management system in accordance with MDR; and/or
• ➣A declaration letter issued by the notified body stating the delay in the issuance of a new certificate.

 

 

References:
For new registration and reregistration of medical devices, the MDA Approach on Expiring EC Certificates