EC Names New Health Commissioner as Pharmaceutical and Device Units Shift to DG Sante

Regulatory NewsRegulatory News | 11 September 2019 |  By 

European Commission President-elect Ursula von der Leyen unveiled her new team of commissioners-designate this week, including the addition of Stella Kyriakides, a medical psychologist from Cyprus, to lead the health portfolio.

Moving forward, Kyriakides’s leadership will be crucial in the implementation of the EU Medical Devices Regulation (MDR), which has a looming implementation deadline next May, and the In Vitro Diagnostics Regulation (IVDR), which has an implementation deadline in May 2022.

Vytenis Andriukaitis, the previous European Commissioner for Health and Food Safety, said in June that the May 2020 deadline is “realistic and achievable.”

And in her letter to Kyriakides on Tuesday, von der Leyen wrote: “I want you to focus on the effective implementation of the new regulatory framework on medical devices to protect patients and ensure it addresses new and emerging challenges.”

DG Grow to DG Sante

In addition to the announcement of Kyriakides, the commission also announced two major changes: “The relevant part of Unit GROW.D.3 (Biotechnology and Food Supply Chain), dealing with pharmaceuticals, moves from DG GROW to DG SANTE - The relevant part of Unit GROW.D.4 (Health Technology and Cosmetics), dealing with medical devices, moves from DG GROW to DG SANTE.”

A spokeswoman from the commission declined to comment further on what these changes might mean for the regulation of pharmaceuticals and medical devices. But experts told Focus that the direction of the unit working on the implementation of MDR/IVDR should remain unchanged, although there might be some lingering concerns.

Gert Bos, executive director of Qserve Group and a RAPS board member, told Focus via email: “This change has been in the books since early spring, and clearly it has been well thought out as it was planned quite a while ago. There will be positives, and obviously some downsides.

“It clearly brings in uncertainty on continuity of the ongoing implementation work. But in a way it comes at a good time, as building block guidance on NB [notified body] designation, UDI [unique device identifier] and EUDAMED are more or less done, and the more content-based guidance and common specifications are largely unavailable but starting to be written at this stage. The key worry in that sense is the building of EUDAMED,” he said.

He also said a new IT team may come on board to help with EUDAMED, so if the transfer from DG Grow to DG Sante “is organised well, there are certainly also upsides as the SANCO IT is well experienced in building and maintaining such database in other areas.”

But an area of concern is on the expert panels for MDR and IVDR. Currently the Joint Research Center of the European Commission has the task to define criteria for these expert panels and should soon start to call for their nominations. “This might be shifting into EMA [European Medicines Agency], some concerned people are indicating, and that would be a first step on a gliding scale towards further EMA involvement in the device arena. As that was one of the inputs into the recast of legislation a decade ago, such note comes with a lot of history attached,” Bos added.


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