Dear Members, please see below request for feedback from MedTech Europe in regard to the EU consultation on reducing environmental administrative burden, if you would like to provide feedback, please not that MTE require feedback by EoB 8th August. Pleasae provide any feedback via regulatory@bivda.org.uk. This would also impact product related reporting requirements for devices placed on the Northern Ireland market, where relevant EUI legislation applies.
Dear members,
This spring, MedTech Europe provided comments to DG Environment’s study contractor Trinomics on the ‘Assessment of Environmental Reporting and the Potential for Simplification. You can find the final comments here: (Attached)
Last week, the European Commission has opened a call for evidence regarding the simplification of administrative burdens in environmental legislation. The call remains open until 10 September 2025.
The adoption of the Commission’s legislative proposal (for a regulation based on article 114 and where considered appropriate article 192 of the EU Treaty) remains announced for Q4/2025.
Background:
- The Commission is currently screening environmental laws to identify legislative acts with significant potential for simplifying administrative tasks. The aim is to reduce the administrative burden without affecting the environmental objectives agreed under the existing legislation. The goal is not to lower the EU’s environmental objectives or the protection of human health granted by EU environmental laws, but to attain them more effectively without causing avoidable costs to businesses (especially SMEs), public administrations and the public.
- The focus is on reducing administrative burden stemming from environmental legislation in the areas of the circular economy, industrial emissions and waste management. This may include the following measures:
- rationalising reporting/notification obligations, for example, the discontinuation of the SCIP (substances of concern in products) database under the Waste Framework Directive;
- harmonisation of the provisions for authorised representatives for extended producer responsibility (EPR) in each Member State where a producer sells a product falling under EPR rules and on facilitation of EPR reporting;
- streamlining reporting obligations, removing double requirements to report, promoting further digitalisation of reporting in the area of circular economy, industrial emissions and waste management, while maintaining the policy objectives;
- addressing permitting challenges relating to environment assessments based on experience recently gained such as under the Net Zero Industry Act.
The list of measures to take could evolve depending on stakeholder feedback and further analysis.
- To identify amendments, stakeholders are invited to provide feedback to this call for evidence. The Commission will also consult stakeholders through their standard consultation activities, such as Expert Groups and Forums. Targeted consultations and reality checks may be undertaken in order to inform the Commission’s work on the present initiative and contribute to putting forward evidence-based EU legislation. Contributions to all stakeholder consultations will be summarised in the staff working document accompanying the proposal.
Request for members feedback:
We suggest responding to the open call for evidence on the basis of our earlier comments on the Trinomics survey and are seeking members further input as soon as possible, but 8 August at the latest.
