First MDR notified body designated in Malta

Malta has reached an important milestone in its medical device regulatory framework with the designation of its first Notified Body under the European Union’s Medical Device Regulation (MDR). The Malta Medicines Authority announced that Malta Conformity Assessment has been formally designated and is now officially listed as the 52nd Notified Body in the European Commission’s NANDO Information System (New Approach Notified and Designated Organisations Information System).

The designation marks a new chapter for Malta’s role within the European medical device regulatory landscape, enabling conformity assessment activities to be conducted locally in line with MDR requirements. This development is expected to support manufacturers seeking compliance with EU regulations, while reinforcing Malta’s regulatory capacity in medical devices and in vitro diagnostics. This achievement is the result of sustained efforts by the Malta Medicines Authority, under the leadership of Prof. Anthony Serracino Inglott, CEO of the Malta Medicines Authority, and Dr. Louise Grech, Director for Medical Devices and Pharmaceutical Collaboration, who played a central role in building the regulatory framework and guiding the designation process.

The establishment of the Notified Body was formally introduced to stakeholders during an event, “Celebration of the establishment of a Notified Body in Malta: Driving Excellence in Medical Device Regulatory Science.” The event brought together key representatives from government, regulatory authorities, and industry to reflect on the implications of this development for Malta’s healthcare and life sciences sectors.

Addressing attendees, the Hon. Minister for Health and Active Ageing, Dr Jo Etienne Abela, highlighted the broader vision behind the designation. He noted that the establishment of a Notified Body in Malta reflects the government’s commitment, together with the Medicines Authority, to support a strong, efficient, and future-ready regulatory ecosystem that ensures the safety and effectiveness of medical devices and in vitro diagnostics placed on the market.

Malta Conformity Assessment was represented at the event by Seval Atkas, Decision Maker & Project Leader of Non-Active Non-Implantable Medical Devices, Malta Conformity Assessment, who outlined the organisation’s role in supporting manufacturers through conformity assessment processes under the MDR framework. MCA’s regulatory engagement also extends to industry dialogue, with Seval Atkas and Salih Oğuz Savaş, Head of Notified Body at Malta Conformity Assessment, having participated in MedTech Malta 2025. During the event, Savaş contributed to the panel “Navigating EU & US Regulations: Key Compliance Trends for MedTech,” offering perspectives on compliance considerations for companies operating across both regulatory environments.

With this designation, Malta joins a limited group of EU Member States hosting MDR-designated Notified Bodies, further positioning the country as an active contributor to European medical device regulatory science. The move also aligns with ongoing efforts to strengthen regulatory infrastructure and support innovation while maintaining high standards of patient safety and product performance.

Continuing the regulatory conversation with MedTech World

Regulatory compliance, market access, and the evolving role of Notified Bodies remain central considerations for MedTech companies operating across regions. These topics are regularly addressed at MedTech World’s flagship events, including

MedTech World Middle East | Dubai, February 11-13

MedTech World North America | West Palm Beach, May 11-13

MedTech World Asia | Hong Kong, Sep 16-18

MedTech World Europe | Malta, Nov 11-13

Each event brings together regulators, manufacturers, and industry stakeholders to exchange practical insights on navigating regulatory frameworks and advancing medical technologies in global markets. Be part of the dialogue.