This article is more than 5 years old. Information may no longer be current.
Trade groups oppose European device reclassifications
AdvaMed and Eucomed calling for evidence-based change.
Click Here to Manage Email Alerts
The trade groups AdvaMed and Eucomed are opposing new device reclassifications proposed by the European Commission.
The organizations contend that the changes, which appeared in the revised Medical Devices Directive, lack scientific backing.
“The commission has released no public information articulating the rationale, analysis or scientific data supporting these classifications,” AdvaMed wrote in a response to the commission.
In addition, the U.S. group wrote that the adjustments would increase production costs and raise the “administrative burden on manufacturers without providing additional safety to patients.”
Higher-risk classifications
The changes move some devices into higher-risk categories. For example, reusable surgical instruments, previously Class I, move to Class IIa. Reorganization without scientific study “adds to the unpredictability of the system,” AdvaMed wrote. The modifications also upgrade some disinfecting, invasive products from Class IIa to Class IIb.
Eucomed, the European equivalent to AdvaMed, holds that shifting disinfectant contact lens solution to this category, for example, “was triggered … by the need to have more control on products which are commonly used by lay persons.” The group also opposes allowing reprocessing of one-time use devices, citing patient safety and lawsuit risks.
Both groups call for alternative action. AdvaMed recommended objective evaluations allowing for guidelines and agency reaction. Eucomed wants the reclassifications eliminated and suggested that the commission substantiate all decisions.
The European commission also recommended the public release of confidential manufacturer conformity reports. AdvaMed challenges the new disclosure. “However, if the commission decides that manufacturer information will be made publicly available, AdvaMed recommends that the manufacturer be consulted prior to publication and given the opportunity to redact proprietary information.”
Industry representatives are also worried about the European Commission’s reclassification initiatives.
Some industry leaders who spoke to Orthopaedics Today said the reclassification is just a tightening of the “regulatory screw.” The type of information proposed under an EU medical products Freedom of Information directive would be similar to what exists in the United States but much less than a European Public Assessment Report for a drug.
“Upclassification is basically political rather than risk-based,” noted Andrew Woodall, quality assurance and regulatory affairs manager with Finsbury Orthopaedics in Surrey, England.
Furthermore, a recent upclassification for orthopaedic implants would not have prevented problems with hips in the United Kingdom, such as with the Capital Hip, he added.
Rather, “Postmarketing surveillance and registry data [is] still be the most effective means of ‘capturing’ problems. Therefore, this presents an increase in cost to industry with no perceived benefit to patients or users,” Woodall said.
Upclassifying reusable instruments would also increase costs, he said. Notified bodies would review products based on sampling.
“There is a difference between manufacturers of just instruments that require no ‘notified body’ involvement and manufacturers of implants that have a fully audited quality [control] system.”