Out-Law News 4 min. read

EU ministers yet to agree on reforms to medical devices regulations

EU countries have still to reach agreement on reforms to the regulation of medical devices, according to new documents published by the Council of Ministers (the Council).

Officials from across the trading bloc have been in negotiations over a new Regulation on medical devices and a separate Regulation on in-vitro diagnostic medical devices for months. Plans to introduce the two regulations were first outlined by the European Commission in 2012.

However, a new progress report on the medical devices reforms (11-page / 304KB PDF) has highlighted areas of the proposed reforms on which Council consensus has yet to be achieved. Agreement will not be reached before the end of this year, the Council said.

The Council must achieve internal agreement on the reforms before opening three-way negotiations with MEPs and the Commission about the final wording of the regulations. The European Parliament agreed its position on the reforms in the spring, but according to a new statement issued, "further discussions are needed for the Council to agree its position".

"Outstanding issues include the aesthetics, reprocessing of single-use devices, the unique device identification system, notified bodies, clinical investigation, tasks of the proposed medical device coordination group, the role of expert panels and reference laboratories, the scrutiny mechanism for certain high risk devices and post-market surveillance," the Council said.

The presidency of the Council hopes to "compile a text covering the two proposals by the end of the year which could serve as a reference text for the incoming presidency" to use to finalise the Council's position, it said.

Under the current presidency's proposals, manufacturers of medical devices would be required to participate in "post-market surveillance" of their products.

The progress report revealed widespread opposition from EU countries to Commission plans to establish a new Medical Device Coordination Group to "scrutinise the preliminary conformity assessment" by certain 'notified bodies' of high-risk medical devices before manufacturers can get a certificate enabling them to place their device on the market. Notified bodies are generally private companies paid by the manufacturers to certify their products. Those bodies will be subject to new minimum standards under the proposed reforms.

However, many EU countries see 'post-market surveillance' as a better way to scrutinise medical devices than have the assessments of notified bodies reviewed before those products are launched to market, the report said.

"Almost all delegations hold that the scrutiny procedure as proposed by the Commission is not possible to apply," the report said. "While many delegations argue that strengthened market surveillance and vigilance measures regarding devices on the market are more efficient than pre-market measures, and therefore believe that a scrutiny mechanism before devices are placed on the market is not necessary, some delegations would wish to include a 'pre-market scrutiny mechanism' for implantable devices in the highest risk class 'Class III devices'."  

The Council said that a compromise was debated by officials in November.

"This discussion showed that some delegations are strongly opposed to competent authorities taking over some of the responsibility now carried by notified bodies," the report said. "Other delegations insisted on increasing the possibilities for competent authorities to intervene in the conformity assessment already at the 'pre-market' stage. The discussion indicated that it is possible to find a compromise, but that further discussion is needed on the requirements on and scope covered by a possible pre-market scrutiny system."

Product liability specialist Manoj Vaghela of Pinsent Masons, the law firm behind Out-Law.com, said: "We see here the tension between getting products to market as quickly as possible to satisfy consumer demand and ensuring that the products on the market provide the level of safety that consumers are entitled to expect. This is not an easy task and the disagreement among the Council of Ministers was predictable, given that different nations have different attitudes towards risk and enterprise."

"There will inevitably be some form of compromise and businesses will hope that it leans towards post-marketing surveillance rather than pre-launch regulatory scrutiny. History shows us that with new technologies, irrespective of the amount of regulatory scrutiny, it is only when a product is used in the real world that the tension between innovation and safety can be resolved," he said. "There is however an urgent need for software applications, such as medical health apps, to be brought within a regulatory framework. Otherwise, consumers, health professionals and health app providers will be working in a fog, without clear demarcation of responsibility."

In March, UK regulator the Medicines and Healthcare products Regulations Agency said that software applications, such as health apps that can be downloaded onto smartphones, could be classed as 'medical devices' in some circumstances.

According to the Council's report, there also remains disagreement about whether to apply the new medical device regulations to 'aesthetic devices'. Aesthetic devices include devices such as coloured contact lenses which have visual rather than a medical purpose. The Commission has proposed that some aesthetic devices should be subject to the new medical device regulations.

According to the Council, the Commission's view has the support of 15 EU countries, with five opposed to the plans on the basis that their inclusion within the new regime would increase "the financial and administrative burden" on regulators. Further discussions are scheduled to identify a "solution that could find broad support", it said.

There is further disagreement over Commission plans to enable medical devices that are supposed to be used only once to be 'reprocessed' so that they can be used again, the Council said. Reprocessing involves the cleaning, disinfecting and sterilisation of used devices, and the re-testing of their "technical and functional safety", among other things.

"While some member states would wish to prohibit entirely the reprocessing of devices that are intended for single-use, others support largely harmonised rules regulating reprocessing," the Council said. "The presidency believes that a compromise proposal that allows member states to prohibit re-processing under national law but provides that if not prohibited re-processing should follow minimum harmonised rules could find support from a broad majority."

Medical devices put onto the market would have to be given a unique device identification to ensure their traceability, according to the Commission's proposals, but agreement over the nature of the system needed to record this information has also still be to achieved, the report said.

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