In 2008, the European Commission planned to make incremental amendments to the EU's medical device regulatory system. Shortly after, the EU became embroiled in two major device safety scandals and it was considered a more comprehensive revision of the rules was necessary. These discussions have now lasted into late 2015.
As a specialist recruiter in Regulatory Affairs within Medical Devices, I’ve got a real feel of the worries felt by medical device companies and the complexities faced as an outcome of this drawn out process. Whilst the need for reforms to the medical device directives has been somewhat inevitable; the agreed details have been an issue of lengthy debate and I worry it’s placed the industry into a position of uncertainty.
What’s the Reform Process & What Will the Reforms Look Like?
In the EU, the legislative process is designed so only the European Commission can introduce new legislation. European Parliament then votes on the proposal & add their changes. Once the proposal is adopted, the Council is tasked with implementing a ‘general approach’ before working with both European Parliament and the Commission to get a final draft.
In regards to our medical device reforms, the proposed are set to affect varying types and classes of devices differently.
One EU regulation would combine existing directives on active implantable medical devices and general medical devices, while the directive (and regulations) on in vitro diagnostics (IVDs) would be reformed too.
The scrutiny is that the EU proposals will phase in general regulations on Unique Device Identification (UDI) and supply chain controls. The Council has also identified several areas for greater scrutiny which are post market surveillance and EU System for Vigilance, clinical trials and of particular interest, the notified bodies.
Erik Vollebregt, partner at Axon Lawyers, highlights the overhanging controversy. “The consequence of these new regulations is that all devices currently on the EU market will have to be CE marked again under the new rules”.
We would expect this to require substantial work to get the dossiers and master files updated across the industry. We should also consider the knock-on effects for notified bodies who will endure a stricter designation process and increased monitoring by the competent authorities. Notified bodies would also be given the authority to carry out unannounced manufacturing site inspections.
The increased burden placed on their resources and expertise could ultimately cause the availability of notified bodies to drop significantly and companies may have to change notified body to re-certify their devices under the new regulations.
Industry group MedTech Europe released a statement welcoming the developments made at the council. Nevertheless, the group has come out against several provisions of the proposed legislation.
My fear is this process seems a bit like trying to change the tires of a moving car with EU member states still not in agreement about certain parts of the regulation. Despite a draft copy of the final text being released, this environment makes it unlikely any new regulations will be adopted until 2016 with implementation through to 2018/19.
Are you in the industry? What are you or your company doing to prepare for what comes next……..?