We audit quality management systems and assess technical documentation for manufacturers placing medical devices on the European market, as a Notified Body designated under Regulation (EU) 2017/745.
Malta Conformity Assessment Ltd. carries out independent conformity assessment for medical devices. Our team works in regulatory affairs, clinical evaluation and technical documentation review.
We audit your quality management system on site to confirm that it covers the whole life of the device, and we keep checking it for as long as your certificate is valid.
Our reviewers assess the technical documentation that shows your device is safe and performs as intended.
Where the regulation allows this route, we audit the quality system that governs manufacturing and final verification, confirming that devices leaving your site match what was assessed.
The steps follow MCA’s published process. Forms are available in the document library.
Send the pre-application form. We review it and send you an offer.
Submit the application form and its annexes with the required documents.
Once the application is accepted, we sign the conformity assessment agreement.
Quality system audit and technical documentation review, as your route requires.
The assessment is reviewed and a certification decision is taken.
Surveillance audits and reviews of changes keep the certificate valid.
When we carry out the conformity assessment for a device, its CE marking is followed by our identification number, 3132. Hospitals, distributors and authorities across the EU can see which Notified Body was responsible.
The manufacturer’s declaration that the device meets Regulation (EU) 2017/745. It lets the device circulate freely within the EU.
Identifies MCA as the Notified Body responsible for the conformity assessment. The same number appears in promotional material that mentions the CE marking.
Shown as a barcode and in plain text. It identifies the device model and its production data, such as the serial number, so the device can be traced through the supply chain.
Flexible Video Endoscope
Model FVE-2800 · Insertion tube Ø 2.8 mm
Technical documentation is reviewed in English. These documents explain fees, terms and how to start.
The head office is in Malta. The Istanbul branch and the Seoul contact office support manufacturers closer to them.
* The international contact office forwards the requests it receives to the head office.
A free online meeting is the quickest way to confirm your route, your documents and the next steps.
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