The first Notified Body under the Medical Device Regulation (MDR) has officially opened in Malta, marking an important milestone for both the local life sciences sector and the wider European medical device landscape.
In simple terms, a Notified Body (NB) designated under the Medical Device Regulation (EU) 2017/745 is an independent, third-party organisation appointed by EU Member States to assess whether high-risk medical devices comply with regulatory requirements before they are placed on the market. Notified Bodies are responsible for reviewing technical documentation, auditing manufacturers’ quality management systems (QMS), and issuing CE certificates—playing a critical role in ensuring device safety, performance, and regulatory compliance.
At present, there are 52 Notified Bodies designated under the MDR. This number has been steadily increasing in response to growing demand from medical device manufacturers worldwide. While some EU Member States host multiple Notified Bodies, others—despite being significantly larger than Malta—do not have any. Against this backdrop, the establishment of an MDR Notified Body in Malta is a noteworthy achievement, both nationally and at a European level.
Malta Conformity Assessment Ltd., through the wider group of companies to which it belongs, brings more than 15 years of industry experience to this role. The group offers a broad range of services, including extensive testing infrastructure, and is backed by a depth of technical and regulatory expertise. Having worked closely with the team, we can personally attest to the strength of their knowledge and experience.
Should you wish to get in touch with this Notified Body, please let us know—we would be more than happy to make an introduction.
More information about Malta Conformity Assessment can be found using the following link
