Implementation of sweeping new rules overhauling how medical devices are regulated in the European Union is just six months away.
Industry has been arguing for more than a year that the system isn't yet ready to handle the onslaught of devices that must be reviewed under the Medical Device Regulation, particularly when the number of notified bodies designated to certify them is much lower than the 20 that the EC expected by year's end, with only seven available so far. The regulation is set to take effect May 2020.
"[D]espite the industry’s efforts to get ready, we remain seriously held back by the slow and piecemeal implementation of the new regulatory framework," MedTech Europe, which represents the EU medical device industry, said in a Nov. 26 statement.
The regulation is intended to increase the intensity of pre- and postmarket reviews and standardize rules for medical devices and diagnostics.
As the rollout approaches, here are four things to know about the state of play, including what parts of the regulation have been delayed, whether additional parts might be delayed, and where the capacity of notified bodies currently stands.
What parts of the new regs have already been delayed and are there more that could be?
The Commission has extended certain deadlines of late, including announcing a two-year delay in the "go live" date of Eudamed, the European Database on Medical Devices, a collection of information on devices sold in the European Union, until May 26, 2022.
Earlier this month, the EC also extended the deadline to apply to serve on expert panels. Under the forthcoming regulation, notified bodies must consult with the advisory panels before clearing certain high-risk devices for marketing in the region.
Manufacturers of certain lower-risk medical devices will likely get additional time to comply with the MDR after the European Council issued Nov. 25 a second corrigendum to amend or modify some parts of the regulation. The corrigendum gives some Class I devices — including certain reusable products like surgical instruments and endoscopes — a four-year transitional period before they are required to meet the new regulation's standards.
Marc Miller, an executive with TransPerfect Medical Device Solutions, a language services and content technology provider to the medical device industry, told the European Commission the device industry needs more time to prepare compliance updates and translate labeling into many languages.
Miller, who would like to see the law's labeling provisions delayed, told MedTech Dive the clinical data requirements and supply chain management provisions are also causing issues.
"I imagine there is some way to delay key aspects of the regulation if there is a public safety concern," Miller said.
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