European Parliament Passes Medical Device Reform Measures

The European Parliament has agreed to new measures that would see an overhaul of the Medical Device Directive, but notably stopped short of requiring a premarket approval system-the likes of which is currently in place in the US-in favor of a slightly more relaxed system of regulation relative to what had originally been proposed by the Committee on the Environment, Public Health and Food Safety (ENVI) in September 2013.

EU legislators have been seeking to overhaul device regulations for nearly two years following a series of high-profile scandals and device failures, including deficient breast implants and faulty metal-on-metal hip implants. The failures were taken by some legislators to indicate that a more rigorous system of premarket review was needed, particularly for high-risk and implantable medical devices.

However, the plans generated by ENVI to respond to the perceived failures received sharp rebukes from industry, which claimed the additional measures would add billions in "unnecessary" costs and delay approval times by years.

New measures voted on by members of the EU Parliament on 22 October 2013 are significantly more lenient by contrast, removing some of the most burdensome requirements.

"The proposed legislation seeks to improve transparency of information for patients and medical staff and to strengthen traceability rules, without creating additional burdens for innovative small manufacturers," Parliament officials explained in a statement.

Among the text's numerous provisions are ones to "reinforce" public access to clinical trials data, the creation of an "implant card" system to allow patients to know which products are inside them, new CE marking requirements to permit only qualified experts to mark devices, new safety rules for IVDs that will require the approval of an ethics board, and new liabilities for device reprocessors.

The legislation now goes to the European Council, which will negotiate the implementation of both files in the "coming weeks" with member states, officials said. "Possible first-reading agreements would then be put to a vote in the Public Health committee before seeking final approval by the full House."

Industry Response

The Parliament's measures have already received a warm response from EU industry group Eucomed, which called it an improvement that is "paving the way to achieve balanced EU rules on medical devices."

"Industry holds the opinion that the Parliament has improved some very essential elements of the approval system, such as clarifying roles and responsibilities of authorities, the Medical Device Co-ordination Group (MDCG), and clinical experts; ensuring Member States authorities are managing the 'scrutiny' system, introducing the concept of utilising a small group from a pool of independent scientific experts to support the MDCG in their decision making and installing high-level expertise and quality amongst Notified Bodies.

"Eucomed believes that further improvements in the discussions with Council should look at building the scrutiny process into the upgraded notified body approval system and not adding it on top of or afterwards which would double or even triple the level of bureaucracy in an already improved system," it continued. " Eucomed now believes that Council and Parliament can concentrate on further improvements, in particular on the medical device approval system, re-processing of medical devices, appropriate clinical requirements and a sensible and scientific approach to hazardous substances."

Read More

• EP debate on devices revision - largely predictable, some surprise (Medical Devices Legal)
• Parliament wants tougher medical devices control without extra burdens for SMEs (EurActiv)
• Parliament wants stricter control on medical devices (EurActiv) (Video)
• EU Parliament stops short of U.S.-style approvals for medical devices (Reuters)
• EU Parliament: No PMAs here please (Mass Device)
• EU Parliament Approves Compromise On Device Reforms - But Will It Be Enacted? (Gray Sheet-$)
• Going for the EU jackpot: Parliament wins fast-track outcome for EU medtech reg negotiations (Clinica-$)
• Medical Devices Face Tighter Rules in EU (WSJ-$)
• EU Lawmakers Back Medical Device Reforms (Law 360-$)