The EU trade association, MedTech Europe, believes that the future success, or otherwise, of the implementation of the EU Medical Devices and IVD Regulations (MDR and IVDR) hinges on decisions that national regulatory authorities and the European Commission will make following the sixth Medical Device Coordination Group (MDCG) meeting, scheduled for September 24 and 25.
MedTech Europe's members have been negotiating extensively with the competent authorities and the ministries of health of EU member states on ways to manage the potential and expected shortage of notified bodies and lack of other critical infrastructure under the IVDR and MDR.
As previously reported, industry is proposing measures such as a ‘stop the clock’ mechanism, or extension of the dates of application. It will be making its case again at the MDCG meeting before the European Commission, and representatives of the national authorities and hoping to get agreement from them on the need for urgent action.
MedTech Europe believes action is critical to cope with the otherwise unprecedented notified body logjam that could force many products off the market as a consequence of having no straightforward way of complying with the EU regulations.
One idea the association has proposed is that the grace period could be extended, both in terms of time and also in terms of the number of products allowed to make use of this extra time allowance under the current medical device directives before having to demonstrate compliance with the new Regulations.
At present, there are huge swathes of medical devices that cannot benefit from the grace period, (otherwise often referred to as the derogation extension, or the soft transition), because they do not meet the criteria of requiring notified body supervision when being CE marked under the current directives.
With the MDCG meeting looming, at which all member states will be represented, the pressure is on to make them see the urgency of devising solutions, whether through voting for amended transitional provisions, or for more flexibility in implementation, or both.
It's "now or never," Oliver Bisazza, director of regulations and industry policy at trade association MedTech Europe, toldMedtech Insight.
Any instrument to do this would need to be enacted by March next year ahead of the May EU elections and the final plenary of the European Parliament. After that, he said, the sector could well be dealing with a new Commission and Parliament, making it very unlikely that any needed corrections to the Regulations could be published before 2020.
industry welcomes the new Regulations, Bisazza said. But to derive the benefits they promise, it is essential for the infrastructure and building blocks of the system to be in place and operational early, he added.
While we want to acknowledge the work that the authorities have been doing, especially in an environment of limited resources, progress has been insufficient.
Manufacturers who want to comply still lack some very essential tools – for example there are no notified bodies yet, no standards harmonized against the Regulations, there are no common specifications, and barely any guidance nor implementing acts.
Yet barely 20 months remain, he said.
Manufacturers who want to comply with the Regulations need urgent reassurances that they will actually be able to do so.
MedTech Europe is not the only stakeholder to be raising issues about the implementation period. A group of MEPs also recently wrote to the European Commission touching on similar concerns.
They have been asking what is being done to prevent medtech product supply disruption and to ensure continuity of care to patients.
While MedTech Europe has put forward its own suggestions to change the terms of the text so that there is adequate time for the structures to be in place for manufacturers to comply in a different timescale than the one proposed in the current versions of the Regulations, Bisazza toldMedtech Insightthat his association is "open to other ideas."
"But these need to enable continued CE marking, and they need to come from the authorities now," he said.
From the editors of Clinica
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