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MedTech Europe warns of ongoing regulatory issues



MedTech Europe welcomed the first wave of new E.U. medical device regulations last week but said there’s work that’s yet to be done.


With the incoming of EU MDR (Medical Device Regulation), a lot of administration and compliance requirements were updated. Many medical device manufacturers are still confused and looking for some guidance. This regulatory shift lost its importance because of the pandemic but now poses a serious challenge for non-compliant medical device manufacturers.

MedTech Europe noted that in the past 4 years much has been achieved in preparing for the new regulatory framework brought in by the EU MDR. This new infrastructure, however, still has areas that need to be worked out and so, for now, they are only partially operational.

MedTech Europe 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 European MedTech industry which is made up of mainly small and medium-sized companies — will continue to hit roadblocks with the new rules until these challenges are resolved. The E.U. Commission and member states need to keep working on them if the EU MDR is to operate successfully for the long-term.

In just under a year from now, the European MedTech industry will need to be compliant with the new In-Vitro Diagnostic Regulation (IVDR), a major overhaul of the current directive. 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.”


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