July 14, 2023
By Yu Seen Ng and Evangeline Loh
We waxed philosophical in our Regulatory Insight about the Global Impact of the European (EU) Regulation (EU) 2023/607. This legislation extends the compliance of legacy devices, under certain conditions.
One of the markets that leverage compliance to the EU legislation is Malaysia.
The Malaysia Medical Device Authority (MDA) has announced their plans to manage the European delays.
Background on medical device regulation in Malaysia
A Malaysia Conformity Assessment Body (CAB) must always be involved in all higher-risk device reviews. However, the medical device regulatory system permits regulatory review efficiencies when manufacturer’s devices are compliant in certain recognized markets: EU, United Kingdom, Australia, Canada, Japan and the US. Circular Letter No. 2/2014 outlines the conformity assessment options. Manufacturers often rely on compliance to the EU legislation.
Devices eligible and compliant to EU requirements would benefit from an abridged CAB review “verification.” It’s important to keep in mind that the CAB cannot be a subsidiary of the Notified Body that performed the EU review.
How will MDA manage delays in the European regulatory system?
The MDA has not explicitly identified Regulation 2023/607. The MDA has acknowledged that CE marking is one method of compliance for the verification process. Malaysian regulators also recognize the need to monitor “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” to permit use of expired CE marking certificates to the Medical Devices Directive MDD 93/42/EEC and the Active Implantable Devices Directive AIMDD 90/385/EEC, under certain conditions.
What are the conditions to extend an expired European Notified Body certificate?
Identical to the conditions from Regulation 2023/607, devices must:
- Continue to comply with the EU legislation;
- Undergo no significant changes in the design and intended purpose (Medical Devices Regulation (MDR 2017/745) Article 120(3)); and,
- Pose no unacceptable risk (health or safety) to patients and users.
What must be provided to the CAB to support this?
As part of the documents submitted in the verification process, the manufacturer must provide the following:
- Competent Authority derogation related to the conformity assessment procedure (MDR Article 59); and/or
- Notified Body letter of conformity assessment application and a written agreement before the expiration of the MDD/AIMDD certificate; and/or
- Notified Body audit report attesting compliance to the quality management system to the MDR; and/or
- Notified Body letter declaring delay in issuance of a new certificate.
It is expected that there will be future clarifications about some of the requirements, as this is currently drafted with “and/or.”
This provides additional impact to global harmonization. While we at Emergo by UL remain ardent proponents of global medical device regulatory harmonization, delays in the regulatory system in a pivotal market can have a “trickle down effect” on others.
Yu Seen Ng is Senior Program Service Specialist and Evangeline Loh is Global Manager, Regulatory Affairs at Emergo by UL.
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