Originally Published MDDI September 2005
|Linda Horton says changes won't affect U.S. companies much.|
Although changes to the European Union's Medical Devices Directives probably won't involve a major overhaul of the regulations or the system, some may still be controversial. The revised draft may bring Europe closer to U.S. standards regarding clinical data requirements, device classification, and a device database. Whether the methods are the right ones appears to be debatable.
“In some ways the European Commission is playing catch-up in terms of tightening certain provisions in the directive related to safety,” says Linda Horton, partner and cochair of European life sciences practice at Hogan & Hartson LLP (Brussels). “The changes in the amendment are incremental and won't have a dramatic effect on companies, particularly in the United States.”
The European Commission drafted the proposed revisions and allowed a public comment period that closed June 25. Discussion of the draft comments probably won't happen until September 2005 at the very earliest, says Horton.
Among the changes are clarified clinical data requirements. In addition to a more thorough review of investigational plans, clinical trials would be required for all devices, including those in the Class I category.
AdvaMed stated in its comments on the revisions that some are inconsistent with the U.S.-EU guidelines. In addition, “some changes to the [directive], such as the up-classification of certain products, have been proposed without scientific evidence to substantiate the need for these changes,” says Janet Trunzo, executive vice president of technology and regulatory affairs at AdvaMed.
The association uses the reclassification of certain reusable surgical instruments from Class I to Class IIa as an example. It states that the change will increase manufacturing costs without offering patients more safety. Trunzo suggests that any regulatory decision making should
• Be science-based and available to the public.
• Involve stakeholders in public dialogue.
• Have a risk-based, least burdensome path to guarantee safety and effectiveness.
One of the trickier areas is defining combination products. In particular, determining a product's primary mode of action still appears to be a murky process.
|Janet Trunzo argues that the need for some of the changes is not substantiated.|
“What's lacking is an administrative mechanism for sorting out combination-product issues,” says Horton. There is no European office of combination products, and establishing one might be a solution down the road.
AdvaMed also objects to the proposed creation of a public database that contains information about manufacturers and products. Confidentiality requirements will be more lenient to allow regulators to better communicate with each other and the public.
“This information should be limited to communications between member states and should not be released to the general public,” says Trunzo. “If the commission decides that certain manufacturer information will be made public, the manufacturer should be consulted prior to publication and given the opportunity to redact any proprietary information.”
To view the European Commission's draft proposal online, visit: http://europa.eu.int/comm/enterprise/medical_devices/consult_docs/Public_Consultation_draft.pdf.
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