Dive Brief:

• The German and Irish delegations to the European Council have raised concerns about the availability and capacity of notified bodies ahead of the implementation of new regulations.

• Writing to the Council ahead of a meeting this week, the delegations brought up many of the fears that trade groups such as MedTech Europe have been voicing for months.

• The delegations aim to avoid delaying implementation "unless absolutely necessary" but are pushing European Union institutions and members to immediately assess their preparations and mitigate certain challenges.

Dive Insight:

Concerns about whether the European Union will be ready for the medical device regulations that are due to come into force in May 2020 have circulated for a long time. In July 2018, MedTech Europe called for the European Union to take urgent action, arguing that the slow pace of progress up to that point meant implementation needed to be delayed. Those concerns centered on the availability of notified bodies. A subsequent survey suggested the industry itself had a poor grasp of the changes.

Against this backdrop of escalating concerns, the European political system has been publicly quiet about the risk of a turbulent, supply-disrupting transition to the new rules. Members of the European Parliament have raised occasional questions but there have been few big signs that the political class shares the industry's concerns.

That changed recently when delegations from Germany and Ireland, the two biggest net exporters of medical devices in the EU, submitted a paper to provoke discussion at a meeting of the Employment, Social Policy, Health and Consumer Affairs Council. The report hits many of the points that MedTech Europe and others have been asking politicians to urgently respond to for the past year or so.

At issue are notified bodies and capacity issues. While only two notified bodies, BSI UK and TÜV SÜD, are currently designated against the incoming device regulation, the EU has pointed to the 38 applications received as of April to show that more capacity will come online soon. The German and Irish report has a less optimistic outlook.

"Based on the number of notified bodies which are expected to be available on time, there will still be significantly fewer notified bodies than currently exist," the delegations wrote in their report. "In addition, data is not available on the capacity these designated bodies will afford the system."  

Constrained capacity could stop manufacturers of medical devices affected by the regulations from complying with the new rules. The regulations feature a failsafe to ensure products can still come to market under their existing certification but, as the delegations note, it only applies to some devices. There is no failsafe for important products including surgical instruments.

While the concerns raised by the delegations closely hew to industry messaging, their proposals for what to do next diverge. The delegations want member states to immediately assess how prepared they are for the regulations but beyond that the response is less urgent than the industry wants.

The next steps proposed by the delegations are the identification and discussion of specific problems and potential solutions. Beyond that, the delegations want to see further discussions involving other pieces of the EU political machinery "before the end of 2019."