With EU legislators now moving ahead with plans to implement a premarket regulatory approval system for medical devices run by the European Medicines Agency (EMA), some in the device industry are beginning to express their fears-loudly-that the proposed changes would stifle innovation in the sector and harm patients by delaying product access.
Earlier in 2013, the European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI) released draft reports calling for the establishment of more rigorous safeguard on medical devices and in vitro diagnostics after a series of notable regulatory failures, particularly with the former.
In response, ENVI Rapporteur Dagmar Roth-Behrendt drafted a plan for medical devices that would see the European Medicines Agency (EMA) given the task of reviewing medical devices under a new 35-member committee known as the Committee for the Authorisation of Medical Devices.
Other proposed changes include regulating devices under a "Class" system similar to that in place in the US, creating a centralized marketing procedure for implantable medical devices, new labeling requirements for reprocessed devices, the establishment of a new Medical Device Coordination Group (MDCG) to advise the European Commission on medical technology, and user fees for devices.
[Editor's Note: A full list of proposed changes may be found in Focus' earlier coverage on the subject. (Here) (Here)]
Since the proposal was first unveiled in April 2013, industry has been aggressively pushing back against the plan. The medical device trade group Eucomed in particular has been a prominent voice on the legislation, arguing that while some change is needed, Roth-Behrendt's plan isn't what is needed.
"Eucomed does not understand the need to call for a pre-market authorization system for Class III devices as Europe currently has a de facto approval system for these devices," the group said in a statement in April. "Europe needs smart regulation that makes efficient and effective use of existing resources and involved structures (European Commission, Competent Authorities, Notified Bodies and industry) so as to retain a simple, adaptable and highly efficient system and merit public confidence."
In the eyes of Eucomed, the current system, in which companies work with outside notified bodies to obtain CE markings, is largely sufficient for its current given purpose. The group also launched a campaign in March 2013 called the "Don't Lose the 3" campaign, referring to gap between the initial launch of a product in the EU and its subsequent launch in US markets. If the current ENVI proposal were to go through, the group postulated, this gap would all either be significantly narrowed or eliminated entirely.
And now Eucomed is taking new steps to try to influence the regulatory discussion-an effort that comes just as ENVI is preparing to take up the device measure for consideration once again.
The group released a survey on 12 September 2013 indicating that the effects of the ENVI proposal could be massive for the industry, costing an estimated €25 billion. The number includes €7.5 billion in investment to "ensure the safety of patients" and a "shocking" €17.5 billion to finance a centralized device regulator at EMA.
While Eucomed said it largely supports the first part of the cost, which includes a unique device identification (UDI) measure and additional administrative requirements, it considers the second too high for comparatively little benefit. Instead it said it favors a "systematic control procedure" in which competent authorities retain control over device regulation. The system is largely analogous to the current notified body system now in place.
The costs were estimated through a survey of 19 medical device companies (8 large, 6 medium and 5 small) conducted by Eucomed, meaning the estimates may well be on the high end of what a proposal could cost.
By way of explanation, the group said estimates costs were grouped into five main areas:
- required clinical data
- increased length and cost of the approval process
- labeling for future new CE marks
- re-use labeling
- administrative implications (inputting data into central databases, etc).
In an accompanying statement, Eucomed said:
"It is crystal clear that our industry is willing and committed to invest in measures that effectively improve the system to ensure patient safety. But asking SMEs to invest additional millions of Euros in a system that will not effectively improve patient safety nor vigilance is outrageous. Not only will it kill the SME and innovation ecosystem in Europe with many jobs, it will also limit innovative treatment options being available to patients."