New European Device Regulations Are Coming, Could Impact Speed of Approvals

Pending formal approval, Europe is set to introduce new rules regulating all medical and in vitro diagnostic devices after the European Council and representatives of the European Parliament came to an agreement on Wednesday. The move is being hailed as a positive development by the European Society of Cardiology.

Announcing the news in a statement, the Council said the new rules are aimed at “making sure that medical devices and in vitro diagnostic medical devices are safe while allowing patients to benefit [from] innovative healthcare solutions in a timely manner.”

The Council said the regulations, which still need to go through a formal approval process, will:

  • Increase scrutiny of devices before they enter the market 
  •  Enhance surveillance in the postmarket setting 
  •  Improve availability of clinical data on devices by establishing a central database 
  •  Require devices to have unique identification numbers to allow traceability through the supply chain 

 “I think you’ll see that . . . these changes that are coming in [offer] much more mid-Atlantic convergence between the European regulatory system and the US system,” Alan Fraser, MBChB (Cardiff University, Wales), chairman of the European Society of Cardiology (ESC) Medical Devices Committee, told TCTMD.

“It is recognized and has been published that there has in the past been a delay in approval often in the States of devices that were first on the market in Europe,” he continued. “And I think in the future that delay will probably become narrower as the FDA encourages special initiatives for innovation and as the European Union tries to engage more with physicians on standards and evaluation and postmarket follow-up.”

He said it is hard to tell whether that narrowing will come more from speedier US approvals or from slower European approvals, but noted that to address industry concerns about delays, the new regulations will contain time limits for various processes.

Nearing the End of a Long Journey

The accord has been a long time coming, according to Fraser. The European Commission started the process in 2008 because of concerns within the clinical community that the regulatory system was not working as well as it should, Fraser told TCTMD. The Commission first introduced a proposal for new regulations in September 2012. Negotiations among relevant stakeholders have continued, but issues surrounding breast implants using industrial-grade instead of medical-grade silicone and concerns about metal-on-metal hip replacements have already led to some reforms, mainly by tightening the application of existing standards, Fraser said.

Two years ago, the European Parliament approved revised device regulations, after which the Council began its deliberations in collaboration with the Parliament and Commission. That is the process that concluded this week after all amendments and revisions were agreed upon. The ESC has been involved throughout the negotiations, Fraser said. 

 The changes still require endorsement by the Council’s Committee of Permanent Representatives and the Parliament’s Environment, Public Health, and Food Safety committee. Then, after revision by “lawyer-linguists,” the regulations will have to be formally adopted by the Council and Parliament. If ultimately adopted, the new regulations will take effect after publication: 3 years later for medical devices and 5 years later for in vitro diagnostic devices.

Broad Support

“The European Society of Cardiology is pleased with these developments because we think the new regulation will reflect many of the conclusions from our policy conference 5 years ago on priorities for the reform of the system in Europe,” Fraser said. 

The details of the agreed-upon draft have not been released but Fraser noted that he has been involved with the process and is familiar with what the major changes entail.

Importantly, he said, there will be requirements for more extensive clinical evaluation of higher-risk implantable devices and a greater amount of clinical evidence to be submitted by manufacturers before approval. Moreover, detailed summaries of the body of evidence for each device will be made available publically.

There have been many reports about how the US Food and Drug Administration (FDA) performs when it comes to evaluating new devices, but that sort of review has not been possible in Europe because the information has not been available, Fraser noted. 

 Now, he said, “it’s going to be possible to see what clinical evidence is available for the devices that we choose from for our patients. We’ve been emphasizing at all stages that we need transparency.”

Another big change will be the formation of specialist expert committees for each of the major medical disciplines. Those bodies will provide advice to regulators regarding approval applications and will produce device-specific conditions for classes of medical devices. 

 “That’s something we’ve also strongly encouraged,” Fraser said, noting that ESC is currently working with the Commission on crafting new device-specific standards for approval of coronary stents as a demonstration project for how the new system will work. The next such document will deal with transcatheter valves, he said.

And finally, the regulations are expected to strengthen postmarket surveillance, ideally conducted independently by professional societies and academia, Fraser said.

MedTech Europe, which represents the medical technology industry, expressed support for the agreement in a statement. “Entering the implementation phase, it is critical that the large volume of secondary legislation transfers this complex framework into feasible and implementable rules, whilst avoiding unnecessary bureaucracy for all involved parties,” the organization said. “The industry will continue to work together with legislators and other stakeholders to achieve this objective.”







Todd Neale is the Associate News Editor for TCTMD and a Senior Medical Journalist. He got his start in journalism at …

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