Erik Hansson remains deputy head of devices in a move to the European Commission’s DG Sante from DG Grow. He now answers to a newly appointed devices head who shares a common educational background but whose recent pharmaceutical role may unsettle the devices industry.
Anna-Eva Ampelas is the newly appointed incumbent overseeing medical devices and diagnostics at the European Commission. She is head of devices unit B6 within DG Sante, health and food safety, and has transferred within the directorate general from overseeing medicinal products.
Her deputy is Erik Hansson - already well experienced in devices and IVD regulation and well known to the medtech sector, speaking frequently at meetings in the EU and internationally.
The medtech sector has historically been very wary of being brought into the same regulatory sphere as medicinal products, which are regulated more stringently, especially in the premarket phase, leaving less room for companies to determine how to best comply with the regulations that impact them. There had been a great deal of friction at the European Parliament during the drafting of the Medical Devices and IVD Regulations (MDR and IVDR); when rapporteur for the MDR file, Dagmar Roth Behrendt was pushing towards introducing more pharma-style regulations for high-risk devices, including centralized pre-market authorization.
So, there is likely to be some concern that Ampelas’ most recent experience has been as head of unit for medicinal products in DG Sante, bringing with it the possibility of pharma-creep into devices regulation.
More specifically, in her previous role, Ampelas was responsible for overseeing medicinal product quality, safety, and innovation, including files on falsified medicines, clinical trials, GMP, health technology assessments and substances of human origin. She has more than ten years of experience working on health policy and legislation in the European Commission.
Erik Hansson, meanwhile, has been one of the constant figures at the European Commission, working on the new MDR and IVDR since discussions began in 2012, and his transfer and continuity of knowledge is being welcomed by industry.
Coincidentally, both Ampelas and Hansson have Masters’ degrees in law from Sweden’s University of Uppsala.
Hansson also heads the EU delegation of the international regulatory cooperation in the International Medical Device Regulators Forum and has been coordinating cooperation with national competent authorities in the framework of the Competent Authorities for Medical Devices Group.
In his move to the devices unit in DG Sante, he loses oversight for cosmetics, which has remained within DG Grow.
Ampelas’ Former Deputy Has Key Medical Products Role Too
Ampelas’ deputy while she was at the pharma unit dealing with the quality, safety and innovation of medicinal products, Agnès Mathieu-Mendes, is listed as deputy head of a parallel unit, B4, which oversees “medical products, quality, safety and innovation.” The head of this unit has not yet been named. Medtech Insight is still awaiting confirmation from the European Commission about the precise role of this unit and whether it is to be focused on medical products in general, as the title suggests, or just medicinal products.
There are eight units in all in DG Sante.