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
On the 18th July, the EU Commission published its updated Q&A document on the practical aspects related to the implementation of Regulation (EU) 2023/607 as regards the transitional provision for certain medical devices and in vitro diagnostic medical devices. We had mentioned this in our recent newsletter and it has been posted on our website. … Read more
On the face of it, this seems simple. Manufacturers can simply self-declare and the Q&A Document states this in section 7. Furthermore, it states that such a self-declaration could be based on a harmonised template. The downfall here is no such thing currently exists. Additional evidence could be provided by Notified Bodies (NB) again by … Read more
The EU have swiftly issued this Q&A document after fast-tracking Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. It’s an interesting document and some will certainly find the information helpful, but in truth, this only clarifies what is … Read more
The much-anticipated amendment regarding the extension of the MDR transitional periods and the removal of the sell-off dates of both MDR and IVDR has entered into force as of 20th March 2023. The amendment was introduced to address the projected shortage of medical devices on the market in the coming years and to address the … Read more
The limited capacity of the Notified Bodies is no secret and is expected to be further affected due to the newly accepted amendment. This can have a substantial effect on the response times and availability for work of the Notified Bodies, which ultimately means that the manufacturer must wait longer than usual for conformity assessments. … Read more
In early January, the EU commission put forward a proposal to extend the transition period for certain medical devices and the removal of the sell-off date for IVDR devices due to concerns of medical device shortages and notified body capacity. In February, the EU parliament has voted by a landslide in favour of the proposal … Read more
Advena is pleased to confirm our return to Arab Heath on January 30th – 2nd February 2023 we will be located in Hall 7 C70. Giving us a fantastic opportunity to meet and greet existing clients and of course the potential of forming new relationships. If you are interested in our EU Authorised Representative service … Read more
Toward the end of December 2022, the MDCG published a position paper aimed at providing a common understanding and approach to the application of Article 97 of the MDR. Giving some hope concerning devices that were certificated under the MDD but have expired since May 2021 or will expire before an MDR certificate is issued. … Read more
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