Dive Brief:
- MedTech Europe has urged the European Commission to act quickly to provide regulatory relief to the device and diagnostic industries, the trade group said Tuesday.
- Working with 35 national associations, MedTech Europe asked the commission to make three changes by the end of 2025 or early 2026. The request for short-term action includes a call for a delay to device re-certification to avoid “a new major bottleneck.”
- MedTech Europe wants officials to implement the changes while working on longer-term reforms, including the creation of a governance structure to oversee notified bodies.
Dive Insight:
A consultation that closed in March revealed the extent of dissatisfaction with European Union regulations on medical devices and in vitro diagnostics. Respondents called the regulations “unreasonably complicated,” “terrible for EU patients and doctors” and “a mess.” In response, officials recently began a call for evidence to inform changes to MDR and IVDR.
In an open letter to the European commissioner for health and food safety, MedTech Europe welcomed the plans to change the legislation, provided the reforms deliver “a regulatory system that is efficient, innovation-friendly, adaptable and well governed.”
Yet the trade group sees a need for EU authorities to advance the reforms in parallel to actions that will provide more immediate relief to the device and diagnostic industries. The request for urgent action includes a call for “a targeted postponement of re-certification requirements for devices already certified under the medical technology regulations.”
The EU has already delayed aspects of MDR and IVDR in response to warnings that tight timelines could force products off the market. MedTech Europe now sees another bottleneck for devices that are due to transition to the regulations by 2028 and is calling for a postponement to ensure continued availability.
In addition, the trade group wants authorities to publish an implementing act that harmonizes the rules for notified bodies. MedTech Europe wants the act to set maximum assessment timelines, define the scope of changes to be notified, remove duplication of vigilance review and enable early talks with manufacturers to mitigate the burden of re-certification.
The trade group’s other short-term request is for the commission to start planned pilots of regulatory pathways for orphan, pediatric and breakthrough devices. MedTech Europe wants officials to run pilots while working to build expedited regulatory pathways into the reforms of MDR and IVDR.
Other requests for longer-term reforms include the creation of “a single and accountable governance structure” to oversee notified bodies. MedTech Europe said the structure should ensure the CE-marking system is efficient and competitive globally.
