As many of our clients are aware, in May we visited Sao Paulo to attend Hospitalar. This event is the largest healthcare event in Latin America and gave us a great chance to engage with manufacturers who are shaping the healthcare industry through their innovation in the space. During the event, we also met existing … Read more
The MHRA has released a draft policy concerning recognition of international regulators’ approvals of medical devices. The policy describes how the MHRA will be able to use the expertise and decision making of other regulatory partners for the ultimate benefit of patients. That being said, the MHRA will retain the authority to reject applications at … Read more
There have been three new notified bodies that have been designated for the MDR. The notified bodies are from Italy, Türkiye and Austria. These new additions bring the total number of notified bodies designated under the MDR to 49. More information on these notified bodies can be found using the following links: NB 0068, NB … Read more
As expected, the EU Council has adopted new rules updating the law on medical devices in order to help prevent shortages and ease the transition to greater transparency and access to information. These new regulations aim to prevent shortages by encompassing the following: The regulation that has adopted will enter into force following publication in … Read more
We are pleased to announce that we will be visiting Medi-Pharm Expo in Vietnam this year. Medi-Pharm Expo will be held in Ho Shi Minh City, between the 1st and 3rd of August at the SECC Saigon Exhibition & Convention Center. Our regulatory associate Sam Attard will be visiting on behalf of Advena and will … Read more
The EU Parliament has also adopted the proposal regarding the gradual roll-out of EUDAMED which will facilitate the launch of parts of the Database. This means that the mandatory use of several parts of EUDAMED will start from as early as Q4 of 2025/Q1 of 2026. This gradual roll-out of EUDAMED will help increase transparency … Read more
The EU Commission has welcomed the adoption by the EU Parliament for the proposal that has been put forward regarding the extension in the transition periods for certain IVDR’s. The new rules will give more time for manufacturers to transition to the new requirements of the IVDR and aims to mitigate the risk of device … Read more
The EU Commission has released a report from a study that they have conducted concerning the reprocessing and reuse of single-use-devices in the EU. The study aimed to evaluate how the provisions that have been established in Article 17 of the MDR, which regulates the reprocessing of Single Use Devices (SUD’s), have been implemented and … Read more
The MDCG has released a guidance document concerning the content of the investigator’s brochure for clinical investigations of medical devices. For some background, when a sponsor of a clinical investigation submits an application in accordance with article 70(1) of the MDR, the application shall be accompanied by the documentation referred to in Annex XV, Chapter … Read more
The MDCG has published a guidance document concerning safety reporting in performance studies of in vitro diagnostic medical devices under the IVDR. For some background, safety reporting in performance studies of IVD’s shall be performed in line with the requirements of Article 76(2) of the IVDR. According to Article 76(2) of the IVDR, the sponsor … Read more
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