We are truly honoured to have been nominated by Med-Tech World in the category ‘Best Consultancy Services in Med-Tech for 2023’. This is the second consecutive year we have been nominated in this category, where in 2022 we won this celebrated award. It would be a privilege to repeat this outstanding achievement in 2023. We … Read more
The 11th Notified Body for Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices has been included in the list of designated Notfied bodies available in the European Commission’s NANDO information system. For the NANDO information system, please click here. For more information … Read more
An update to the Manual on Borderline and Classifications under the MDR and IVDR has been published. The last update, version 2, was issued in December 2022, and since then has been updated to include the following devices: Root canal irrigation solutions, Temperature sensors embedded in orthopaedic devices for compliance tracking, System intended to produce … Read more
On June 21, 2023, the Official Journal of the European Union published the Implementing Regulation (EU) 2023/1194 amending the transitional provisions laid down in Implementing Regulation (EU) 2022/2346 for certain products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 (MDR). This document has been adopted to align the transitional provisions … Read more
This month sees an updated EUDAMED, version 2.12 was deployed on 20th September 2023. It is important that all actors keep informed regarding these changes and how they may affect the use of EUDAMED. The release notes detailing new and updated elements can be found here: [Release Notes v2.12] The EUDAMED user guide for Economic … Read more
In a open letter sent to the Commissioner for Health, MedTech Europe provides a damning assessment of the current regulatory position in the EU. ‘The regulatory framework is unpredictable, complex, slow and costly. The result is that medical technologies – both those already on the market and future innovations − struggle to reach European patients … Read more
Surveillance by the notified bodies is a condition that needs to be satisfied in order to make the manufacturer eligible for the extension in the transitional periods. Usually, the surveillance activities would be undertaken by the notified body that issued the CE certificate under the previous directives, as stated in Article 120 (3) the MDR. … Read more
Regulation (EU) 2023/607, that has been adopted in March 2023, amends the transitional provisions for certain medical devices covered by the Medical Device Regulation (EU) 2017/745 (MDR). The transitional provisions were introduced in order avert any risk critical medical devices shortages in the EU market and to help with the limited capacity of the notified … Read more
The MHRA has designated three new UK approved bodies, almost doubling it’s capacity for the certification of medical devices. There are now a total of seven UK approved bodies in the UK. These approved bodies play an important role in the medical device industry by helping manufacturers to get their device on the market and … Read more
As many manufacturers currently know, there are many conditions that you must satisfy in order to be eligible for the extension in transitional periods. Although these conditions are stated on the EU 2023/607 document, reading through these conditions, and subsequently determining the applicability could get confusing, and at times hard to follow. In light of … Read more
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