MDA has taken an approach to allow expired EC Certificates to be used for conformity assessment procedures 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.
This approach is applicable if the following conditions are met:
i. The devices continue to comply with Directive 90/385/EEC and 93/42/EEC; and
ii. There are no significant changes in the design and intended purpose; and
iii. 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.
The following supporting documents shall be provided for conformity assessment by way of verification process:
i. A formal letter from the national competent authority that has granted a derogation from the
applicable conformity assessment procedure; and/or
ii. 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
iii. An audit report as evidence that the manufacturer has put in place a quality management system
in accordance with MDR; and/or
iv. A declaration letter issued by the notified body stating the delay in the issuance of a new
certificate.”
For further details, please refer to: https://portal.mda.gov.my/announcement/1224-announcement-mda-approach-on-expired-ec-certificate-for-new-registration-and-re-registration-of-medical-device.html