We are now over 15% of the transition period of the new European IVD Regulation (IVDR) and over 25% of the Medical Devices Regulation (MDR) transition. That said, transitioning to the new system comes with highly-ambitious timelines, and success will require great effort, by industry and authorities alike.
Last week, at the Association of the European Self-Medication Industry’s (AESGP) regulatory conference, I presented MedTech Europe’s vision to the Heads of EU Medicines Agencies. In most Member States, these agencies are the home of our IVD and medical device competent authorities, meaning that the heads of these agencies bear ultimate responsibility for the successes (and failures) of our present regulatory journey.
Building on MedTech Europe’s political messages for a successful IVDR and MDR implementation, our messages to the regulatory leaders are:
The new Regulations are 2-3 times larger than the former Directives and they’re more detailed and burdensome, for business and for regulators.
Good regulatory practice states that authorities need expertise and resources proportionate to the legislation they implement.
After 50+ years of EU pharmaceutical legislation, most of our industry’s competent authorities sit in agencies with excellent pharmaceutical expertise. Several even have respectable medical devices’ expertise. Only a few have noteworthy IVD expertise and nearly none have ‘enough’ general expertise and (human) resources to properly implement the new Regulations.
To their credit, several agencies are staffing up or would like to. Not many have received enough support – financial or political – from their leaders in the Ministries. Where support exists, it’s often challenging to find suitably trained people, especially in IVDs and emerging technologies.
This needs to improve and quickly. Industry and Notified Bodies are already recruiting the best people they can find, and national authorities will struggle to compete in this well-tapped labour market. If staffing up is not an option, authorities should at least train their existing teams. Both approaches can help, in the long-term.
In the shorter term, authorities should consider re-assigning (even temporarily) staff from other departments. The race is currently on to get 50+ Notified Bodies (re-)designated against the new requirements. The system depends on the timely availability of Notified Bodies and agency heads should do everything they can to make this happen.
Money isn’t everything. Well-functioning systems need strategic vision, too.
The European Commission’s new governance system is finally up and running: The Medical Devices Coordination Group (MDCG) is active, and many new working groups are busily developing guidance and other tools.
We have a problem, though — Brexit. The UK competent authority (MHRA) leads several important implementation initiatives, both within the MDCG and within the Competent Authorities for Medical Devices (CAMD) network.
With Brexit approaching, we need more national authorities to come forward and lead. Some agencies – like in Denmark, Ireland and Sweden, for instance – have volunteered to lead new working groups. All others should follow this good example. If each competent authority leads the implementation of just one topic dear to its heart, then the new MDCG will deliver results much quicker.
Within CAMD, needs are even greater. MHRA has been an exemplary CAMD Chair by helping to implement individual pieces of the new system. Under Workstream #8 of its Implementation Roadmap, CAMD also tackles “overarching and cross-cutting priorities” of strategic importance, like:
– Common interpretation among authorities regarding transitional provisions
– Contingencies and scenario planning around the availability of Notified Bodies, authorised representatives, and other actors upon which the system depends, and
– Risks of increased regulatory burden threatening supply of low-volume products like many IVDs
These are precisely the kind of considerations that should keep our authorities awake at night. A new CAMD Chair that can continue and even deepen this strategic approach will help tremendously. Bring your best and brightest people!
Finally, we would like to see agency heads to personally engage in this journey. Why? Well, historically, pharmaceutical objectives have dominated these agencies’ agendas, and this won’t change overnight. But change is a must, as the realities of the IVDR and MDR draw near.
Competent authority staffs are working hard, with limited resources and little time. Legal deadlines and individual projects take up considerable energy. While this happens, agency heads should monitor how the new regulatory system’s building blocks are evolving.
How is Eudamed progressing? Are all needed Implementing Acts coming fast enough? What about harmonised standards? And never forget the Notified Bodies!
Someone needs to ensure the system as a whole functions…and who better to do that than those who bear ultimate responsibility for the system?
So please, dear agency heads, engage personally in this fledgling regulatory system. Keep implementation on-track, and intervene if it does not. If done right, our new regulatory system has the potential to be one of the most modern and mature system in the world and it will deliver big wins for safety, quality and performance.
With your help, we have our best shot at success!