EC Certificate (CE Marking) pursuant to Directive 90/385/EEC and 93/42/EEC is one of the approval types that is recognised by Medical Device Authority (MDA) for conformity assessment procedure by way of verification process for the purpose of medical device registration in Malaysia.

In principal, the certificate shall be valid during the new registration and re-registration submission. However, due to the unpredictable timeline and issues with regards to the transition to the EU MDR, and to ensure continuous supply of the medical device in the market, MDA has taken an approach to allow expired EC Certificate to be used for conformity assessment procedure by way of verification process with the registered CABs if the following conditions are met:

  1. The devices continue to comply with Directive 90/385/EEC and 93/42/EEC; and
  2. There are no significant changes in the design and intended purpose; and
  3. 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.

Additionally, the following supporting documents shall be provided for conformity assessment by way of verification process:

  1. A formal letter from the national competent authority that has granted a derogation from the applicable conformity assessment procedure; and/or 
  2.  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
  3.  An audit report as evidence that the manufacturer has put in place a quality management system in accordance with MDR; and/or

  4. A declaration letter issued by the notified body stating the delay in the issuance of a new certificate.

 

 

Medical Device Authority

Ministry of Health Malaysia

27/6/2023

 

Updated: 27 June 2023