While acknowledging that the May 2020 deadline for the implementation of the new medical devices regulation (MDR) is a “significant challenge,” the European Commissioner for Health and Food Safety said Friday that the industry and government “are on course to meet it.”
Vytenis Andriukaitis’s comments at a meeting of EU Ministers for Employment, Social Policy, Health and Consumer Affairs (EPSCO) in Luxemburg followed concerns raised
this week by German and Irish delegations to the Council of the EU over notified body (NB) capacity and the implementation of MDR.
As far the “crucial issue” of NBs, Andriukaitis said 51 NB applications have been received by the EC as of Thursday, 29 joint assessments have been performed and the two biggest NBs have been designated (BSI
and TÜV SÜD
) and hold a significant share of the certificates.
Based on current information, the EC expects 20 NBs to be designated before the end of this year.
And although the number of NBs under the new regulations could be lower when compared to now (Lloyd's Register Quality Assurance (LRQA) said Wednesday
that it will not apply to be an NB under MDR/IVDR), Andriukaitis said: “This is not a surprise… Stricter requirements have been set to ensure that future notified bodies are fully fit for purpose. On the other hand, this will mean higher capacity in designated notified bodies.”
As far as progress achieved so far, Andriukaitis pointed to the preparation of the Eudamed database
core modules, which will be functional in line with the deadlines, the establishment of the unique device identifier system and work on implementing acts, including one on expert panels, which he said is close to being finalized.
In terms of postponing the transition period, Andriukaitis said that “any change of rules at this late stage would be unfair to serious operators that have carried efforts to ensure their timely compliance.
“In conclusion, May 2020 is a realistic and achievable deadline … and the implementation process remains a shared responsibility among all partners, including member states, NBs and operators,” he added.
In agreement with the concerns raised by Germany and Ireland, Nicola Blackwood, UK’s Parliamentary Under Secretary of State for Health (Lords), said Friday she’s also concerned about “the readiness of critical infrastructure,” noting “there’s an increasing likely risk that the system won’t be ready” by next May.
She said the “principle concern” is that NBs will not be designated in time or have the capacity to deal with newly up-classified devices in addition to their existing portfolios.
“This is likely to delay patient access to a large number of devices,” she added. “We will continue to work to ensure implementation in a timely manner… but we have to have plans in place to mitigate those risks” of implementation not meeting the May deadline.