With six months to go before the EU’s new Medical Device Regulation takes effect, Europe’s medtech trade association is accusing government authorities of dragging their feet on the process.
MedTech Europe said that the industry is trying to prepare but that it remains “seriously held back by the slow and piecemeal implementation” of the new regulatory framework.
“As we have maintained throughout the regulations’ transition periods to-date, this incomplete implementation by the EU member states and European Commission threatens the continuity of patient access and care, both in Europe and in the more than 100 countries around the world that rely on the EU CE marking of medical technologies,” MedTech Europe said in a statement released today.
The group acknowledged the increased political attention to the MDR in recent months, as well as efforts by the commission and member states to solve challenges such as the lack of notified bodies to determine whether previously cleared devices comply with the new regulations.
As of Nov. 25, there were seven such bodies designated under EU MDR and 10 more that have confirmed they are waiting for MDR designation, according to regulatory consulting firm Oriel Stat A Matrix. MDR is scheduled to take effect May 26, 2020. The EU has confirmed two notified bodies for the In Vitro Device Regulation (IVDR), which goes into effect in May 26, 2022.
MedTech Europe also criticized the EU for paying less attention to IVDR than to MDR. IVDR presents a “considerable challenge” because 85% of more than 50,000 IVDs will need certification by notified bodies in the next 30 months — equal to more than 330 IVDs per week, the group noted.
“Although 2.5 years still remain until the IVDR’s date of application, MedTech Europe is alarmed that only about 10 organizations have applied so far to be notified bodies under that regulation,” the trade group said. “Of these 10 organizations, only two have received their license to operate (i.e., their ‘notification’) as notified bodies under the regulation.
“Given that the IVD regulation brings an estimated eight-fold workload increase to IVD notified bodies, it is clear that the EU needs to start urgently and proactively addressing this situation if patients and healthcare systems are to retain access to diagnostic tests,” the group concluded.
