The European Commission calls for evidence

By Annette van Raamsdonk 

On Oct. 24, 2024, we informed you that the European Parliament submitted a resolution to the European Commission (EC) to drastically change the Medical Devices Regulation (EU) 2017/745 (MDR). In addition to the resolution, stakeholders have sent out numerous calls for action to the EC to revise the MDR and In Vitro Diagnostics Devices Regulation (EU) 2017/746 (IVDR): to make them more predictable and cost-efficient, to reduce administrative burdens so that small and medium-sized companies can also survive, and to get innovative devices to the market.

The EC finally seems to have realized that the path forwards with the current regulations, does not “ensure the smooth functioning of the internal market as regards medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small- and medium-sized enterprises (SMBs) that are active in this sector (recital 2),” which was the aim of the MDR and IVDR. Neither is a “robust, transparent, predictable and sustainable regulatory framework (recital 1)” established that supports innovation. Therefore, the EC has launched another consultation and calls for evidence. 

About the consultation

This new consultation is open for a short time frame only, from Sept. 8 to Oct. 6, 2025. The aim of the consultation is to “simplify and streamline the regulatory framework, and make it more cost-efficient and proportionate, while preserving a high level of public health and patient safety and maintaining the overall structure of the current regulatory framework.” 

The main goals the EC aims to achieve through this consultation are: 

• Reduction of the administrative burdens, including reporting obligations (for Notified Bodies towards Competent Authorities, as well as likely the recurrence of conformity assessments for the maintenance of certificates)
• Making the regulations more predictable and cost-efficient
• Applying proportionate conformity assessment requirements, considering the risk class of the device in question and the special needs of patients
• Enabling further digitalization
• Streamlining procedures, including those on governance, for example, to avoid conflicting guidance
• Supporting more international cooperation, including reliance, where appropriate (think of leveraging medical device single audit program (MDSAP) certificates to fulfill part(s) of the EU quality management system (QMS) requirements)
• Better aligning the regulatory framework with other relevant legislation, such as the Battery Directive, AI Act and so on

Previous consultation and the current strategy  

The EC has summarized and analyzed the public consultation that took place from Dec. 12, 2024, to March 21, 2025. The EC’s current strategy addresses all points, builds on the previous public consultation report, and actively involves SMEs. It also sends targeted surveys to stakeholders and collects feedback during workshops with stakeholders. 

Over the past months, the EC has already started organizing several workshops with stakeholders such as the European Association of Authorized Representatives (EAAR), of which Emergo by UL is a member. During these workshops, topics such as reducing the administrative burden, enhancing innovation, and making market access easier were discussed. 

The EC has indicated that it aims to have a draft document ready by the end of this year.

Concluding remarks

The EC has realized that proceeding with the current regulations would potentially lead to shortages of medical devices and innovation being brought to a halt. While not everyone will get enthusiastic about “another regulatory change,” Emergo by UL welcomes the EC’s effort to make the EU market a market that cherishes SMBs, is transparent and accessible for manufacturers of safe and innovative medical devices, not only from the EU but also from third countries.

Emergo by UL takes part in several European Commission Medical Device Coordination Groups (MDCG) and will keep you updated.