As many of our clients are already aware, registration in the European Database on Medical Devices (EUDAMED) became mandatory on 28 May 2026. From this date, all economic operators wishing to place medical devices or in vitro diagnostic medical devices on the European Union market must comply with EUDAMED registration requirements in accordance with the … Read more
We’re pleased to announce that this edition of the newsletter as well as future editions will also be available in a video summary format, offering a convenient way to catch up on the latest regulatory updates. To watch the full video summary for the month of May, please click on video below.
The European Commission has published a new Implementing Regulation introducing uniform requirements for conformity assessment activities carried out by notified bodies under the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). The new rules are intended to promote greater harmonisation, predictability, and efficiency within the EU medical device regulatory framework. They … Read more
MedTech Europe has published a position paper outlining its views on the proposed revision of the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). According to MedTech Europe, the European regulatory framework for medical technologies has reached a critical stage. The organisation supports the European Commission’s efforts to streamline … Read more
The EU Commission has updated the results of the Study Supporting the Monitoring of the Availability of Medical Devices on the EU market. This new update is concerning a period ending in December 2025. The results have been documented in a .pdf power point which is split up into 5 sections: To offer some background … Read more
The Medicines and Healthcare products Regulatory Agency (MHRA) has published a questionnaire to gather feedback on the anticipated impacts of the Medical Devices (Amendment) Regulations 2026. The questionnaire is intended to collect information on the costs and benefits associated with the proposed regulations, which aim to strengthen safe access to medical devices and in vitro … Read more
We are pleased to announce that Advena will be exhibiting at MedTech Expo NEC 2026 in June. The fair will be held on the 3rd to 4th June at the National Exhibition Centre (NEC), Birmingham in the UK. Representing Advena at the event will be our CEO & Managing Director Anthony Kirby and our Regulatory … Read more
As the EU regulatory framework for medical devices and in vitro diagnostic devices continues to mature, May 2026 marks a critical milestone for manufacturers operating under the Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostic Regulation (EU) 2017/746. Several high-priority deadlines will take effect during this month, requiring immediate attention to ensure ongoing … Read more
We’re pleased to announce that this edition of the newsletter as well as future editions will also be available in a video summary format, offering a convenient way to catch up on the latest regulatory updates. To watch the full video summary for the month of April, please click on video below.
Medical device classification in the EU follows a risk-based approach, considering factors such as invasiveness, duration of contact, and potential impact on the body. These criteria, set out in Annex VIII of the MDR, guide manufacturers in assigning the correct class, which in turn determines the level of regulatory scrutiny and conformity assessment required. The … Read more
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