MedTech Europe welcomed the first wave of new E.U. medical device regulations this week, but said there’s work that’s yet to be done.
The trade group noted that EU MDR — the new regulatory regime for medical devices — strengthens the system of notified bodies, or companies that conduct audits on each device whose manufacturer is seeking entry to the E.U. market. It also provides a new database to enable more transparency, a unique device identification system to assist with supply chain traceability, and stricter clinical evidence requirements. EU MDR replaces the EU Medical Device Directive (MDD), with today ending the first phase of implementation.
While some positive progress was achieved in preparing the new infrastructure over the past four years, some key pillars of that infrastructure are still not fully operational or even in place, MedTech Europe noted. It listed the following challenges that the medtech industry continues to face:
- Non-harmonized interpretation and application of MDR rules across the EU.
- Limited capacity among notified bodies, especially for certification of new and innovative devices.
- Uncertainties about pending discussions on the rules and agreements between the EU and other countries, especially Switzerland, a key supplier of medical devices to the European Union.
- Unpredictable recognition of MDR certifications at the international level vis-à-vis regulatory approvals from other jurisdictions.
The medtech industry — especially small and medium-sized companies, which constitute the majority in Europe — will continue to hit roadblocks with the new rules until these challenges are resolved, the trade group warned. The E.U. Commission and member states need to keep working on them if EU MDR will work long-term, it added.
The European medtech industry has one more year before it must comply with the In Vitro Diagnostic Regulation (IVDR), a major overhaul of current regulations. While the industry supports the new regulations, the system isn’t ready to support its implementation, the trade group said.
“Due to the complexity of the Medical Device Regulation and the delay in the new system’s full readiness, European patients are losing their previous opportunities to be the first to benefit from critical medical technology innovation,” said MedTech Europe CEO Serge Bernasconi in a news release. “Solutions envisaged for MDR and IVDR should avoid unnecessary bureaucracy and most importantly ensure legal certainty, predictability and space for innovation to bloom in the EU.” Medical Design and Outsourcing