Just 27% of 230 medical device makers surveyed expect to be in full compliance with the European Union’s Medical Device Regulation (MDR), which goes into effect in May next year, a study has found.
The Regulatory Affairs Professionals Society (RAPS) and US tax, audit and advisory firm KPMG surveyed companies internationally, with 91% of participants from the EU and North America.
Of those surveyed, 46% said they will leverage the MDR’s transitional provisions to be able to sell their products in the EU until 2024, while working on their compliance programs.
The survey, which closed in June 2019, also revealed concerns that only five notified bodies (NBs) have so far been designated as medical device inspection authorities, which must assess medical products before they can be marketed in the EU.
WHY IT MATTERS
Concerns that the industry is not able to fully comply with the new regulation have been echoed by European trade associations MedTech and the Association of British HealthTech Industries (ABHI).
Oliver Bisazza, MedTech director for regulations and industrial policy, told MobiHealthNews: “The medical technology industry remains committed to full compliance with the EU MDR’s new requirements. However, we cannot do so. The new regulatory system is not yet ready to function at full speed.”
Meanwhile, an ABHI spokesperson said: “Conformity via an NB is an essential part of the medical device approval process for devices above class one status. Without it, products cannot reach patients.”
THE LARGER CONTEXT
The new EU MDR came into force on May 5, 2017, replacing two existing directives. The new regulation applies after a transitional period of three years, which falls on May 26, 2020.
Existing devices which have been CE marked under the current EU Medical Device Directive (MDD) must be recertified to abide by the new MDR, which includes tighter regulatory controls and enhanced market surveillance.
ON THE RECORD
Rajesh Misra, an advisory principal at KPMG, said: “Without adequate planning and budgeting, EU MDR compliance efforts could lead to strained resourcing, employee resistance, insufficient training, and communication failures across the organisation – causing barriers to get EU MDR compliant products to the market.”
RAPS executive director, Paul Brooks, said: “If there are too few NBs or their capacity to assess devices under EU MDR is inadequate to meet the demand, it will create bottlenecks that could result in product shortages, including for critically important and high-risk devices patients depend on.”
Bisazza of MedTech, said: “We believe that building up the new regulatory system needs a dramatic acceleration and should avoid putting patients at risk or negatively impact healthcare systems.”