EU Commission Release Information on the Applications for Designation as a Notified Body
The EU Commission have released an overview of CAB/NBs at each stage of the designation process. The document shows the different stages of the designation process and how many organisations passed each stage. The data shows that a total of 21 and 62 organisations have lodged applications SANTE F for the IVDR and MDR respectively. ...
The EU Commission Has Commissioned a Study Monitoring the Availability of Medical Devices on the EU Market
The study is focusing on two key stakeholder groups, manufacturers and authorised representatives. The outcome of which, is to effectively monitor the availability of medical devices (including in-vitro diagnostic devices) on the EU market and the insights from these two key stakeholders are deemed essential. This study will be conducted repeatedly over a three year ...
MDR and IVDR Communication Survey
The EU Commission published a survey in August 2023, this survey is due to close by the end of November 2023. It is only intended for stakeholders who are directly impacted by the regulatory changes for medical devices. That would seem to be a great number of organisations. The object of this survey is to ...
Advena Nominated for Best Consultancy Services in Med-Tech for 2023
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 ...
MedTech Europe Sends Open Letter to EU Commissioner for Health, Stella Kyriakides.
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 ...
