Medical Device Authority (MDA) only recognized EC Certificate (CE Marking) issued under Directive 90/385/EEC, 93/42/EEC, or 98/79/EC, or, EC declaration of conformity for IVD medical devices by Directive 98/79/EC (applicable only to Class B IVD medical devices under the Medical Device Regulation 2012) as an approved conformity assessment procedure through a verification process for medical device registration in Malaysia.
However, due to the unpredictable timelines of the EU MDR and IVDR transition, MDA decided to loosen the requirements for new and re-registration submissions.
On 22 August 2024, the Medical Device Authority (MDA) introduced a revised protocol that permits the use of expired EC Certificates for conformity assessment, provided the following conditions are met:
The devices continue to comply with Directive 90/385, 93/42/EEC or 98/79/EC; and
There are no significant changes in the design and intended purposes; 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
Additionally, manufacturers must submit the following documents to support the verification process:
Formal letter from the national competent authority that has granted a derogation from the applicable conformity assessment procedure; and/or
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 before the expiration of the certificate; and/or
An audit report as evidence that the manufacturer has put in place a quality management system per MDR and IVDR; and/or
Declaration letter issued by the notified body stating the delay in the issuance of a new certificate; and/or
Self-declaration by the manufacturer confirming that the conditions for the MDR or IVDR extension are fulfilled, stating the end date of the transition period. Such self-declaration should identify the devices the extension covers and the certificates concerned. The self-declaration letter shall be supported by a confirmation letter issued by the notified body stating the receipt of the manufacturer’s application for conformity assessment.
Source: Medical Device Authority (MDA)
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