European medical device makers continue to fight back against proposed healthcare regulations that would add a new layer of pre-market review to the medtech approval pathway.
Device lobby Eucomed issued a handful of recommendations in response to the European Commission’s "scrutiny panel" model, which would designate a central FDA-like body to review medical devices after they had already gone through the existing certification process.
"We don’t see this proposed extra layer as bringing anything significant to the game," Eucomed CEO Serge Bernasconi told MassDevice.com during an interview in September. "In particular, when it relates to patient safety, fast access to technology for patients and further development of innovation in Europe, which has been fertile ground for developing innovations."
In response to the new proposal Eucomed today released a detailed position paper calling for checks and standards for existing "Notified Bodies" responsible for postmarket review, strengthening the current medtech review process in lieu of adding another layer.
The European Commission’s new guidelines, which the agency issued in September, aimed to fulfill a European Parliament request for more stringent medtech scrutiny by bolstering an existing pre-market review system with additional checks and more transparency.
The EU already has a mechanism in place for pre-market review of high-risk devices, but the new proposal would grant member states the ability to analyze and comment on assessments performed by Parliament’s Notified Bodies.
"The measure would address some political calls to move the system towards a centralized pre-market authorization system as found in the U.S. but will ultimately result in harming European patients and negatively impact mostly European small and medium sized enterprises," Eucomed said in a statement issued last fall.
The lobbying group reiterated many of those sentiments today, warning that a move to a more FDA-like regulatory system would compromise Europe’s lead in patient access to medical innovation.
"Various reports from respected academics and researchers have shown that the European decentralized system makes medical devices available to patients 3-5 years earlier than e.g. in the United States without compromising safety," according to a press release. "The proposed scrutiny procedure is inappropriate because it is a random sampling process of certain medical devices and the timing of the scrutiny occurs very late in the approval process – after the Notified Body has finished its assessment. The proposed measure creates a false sense of security and is essentially ineffective and inappropriate."
The lobbying group was particularly focused on the oversight of Notified Bodies, calling for "comprehensive systematic control procedures" for ensuring that participants are up to standards and that clinical evidence is properly reviewed by independent experts.
"This systematic control procedure would replace the proposed scrutiny procedure, which is essentially a duplication of reviews and checks and does not contribute to patient safety," according to Eucomed.
Eucomed summarized the key points as follows:
- Only the best Notified Bodies should be allowed to approve medical devices to the market in order to ensure that the backbone of Europe’s decentralized system meets the highest safety and quality standards.
- A systematic control procedure is necessary to improve the system and increase patient safety. The proposed ‘Commission scrutiny procedure’ (article 44) is inappropriate because it is not systematic and will not lead to increased patient safety. It should be replaced with a systematic control procedure (that goes beyond the current proposed measures). Only then will we reach the outcome that is desired by all stakeholders: maximum safety for all Europeans without unnecessary delay or duplication of work.
- Increase stakeholder involvement to ensure that the opinions of essential healthcare actors are heard.
- Greater transparency and traceability is critical to ensure that patients, doctors, industry and other stakeholders have access to clear information about the medical devices they use.
- Clinical evidence needs more clarity as clear, appropriate requirements for clinical evidence are paramount to demonstrate that devices perform well and are safe for patients when used by a well-trained healthcare professional and as intended by the manufacturer.
- Enhance vigilance and market surveillance to allow for rapid identification of adverse events and to ensure coherent and timely action by Member States.
- Clear science based classifications are needed to avoid the currently proposed arbitrary reclassification of families of medical devices without any scientific or other justification, which will lead to global confusion. Clear and science based procedures must be followed to ensure that devices are appropriately classified.
European authorities have been assessing medtech review standards, which haven’t changed much in 2 decades, since the European Commission in 2008 identified several vulnerabilities. Regulators came under intense pressure to revise security standards for medical devices after a wide-scale breast implant recall dramatically exposed weaknesses in the system.
The European Parliament in June 2011 voted in favor of a new PMA process after French breast implant company Poly Implant Prosthèse was forced to recall 30,000 sets of breast implants after regulators discovered they were filled with substandard silicone.