Dear Members please see below MedTech Europe update:
In July 2024, the reset of the EU Institutions reached its next level: the European Parliament renewed the mandate of MEP Roberta Metsola (EPP/Malta) as President of the European Parliament for another 2.5 years and elected Ursula von der Leyen as EU Commission President for a second term running from 2024 to 2029. On the occasion, Mrs von der Leyen presented her Political Guidelines with seven headline priorities for the new policy cycle. These put “A new plan for Europe’s Sustainable Prosperity and Competitiveness” at the forefront and set out six further political priorities, i.e.: “A new era for European defence and security”, “Supporting people, strengthening our societies and social model”, “Sustaining our quality of life; food security, water and nature”, “Protecting our democracy, upholding our values”, “A global Europe: leveraging our power and partnerships” and “Delivering together and preparing the Union for the future”. “We must and will stay course on all of our goals, including those set out in the European Green Deal”, she stated. On the occasion, MedTech Europe issued a press statement. An overview summary of the Political Guidelines is included at the end of the Green timelines document attached. Besides, EP Committees constituted and elected their new chairs. Antonio Decaro (S&D/Italy) has been elected chair of the ENVI Committee. Borys Budka (EPP/Poland) leads the ITRE Committee. MedTech Europe is now up for rebuilding relationship with new MEPs.
As regards our Sustainability and Environment advocacy work, we report the following key developments for July 2024:
- Chemicals Policy: Following the adoption of the Council’s General Approach on the One-Substance -One-Assessment (OSOA) package, we published MedTech Europe’s views and recommendations for the further proceedings. Similarly, as the EU Commission released its Essential-Use-Communication, MedTech Europe finalised its analysis and published a reflection paper for next steps. Besides, MedTech Europe submitted its response to the EC consultation on dechlorane+ and provided an updated list of medical technology uses of F-gases.
- Circular Economy: Upon entry into force of the new EU Sustainable Products Regulation (ESPR), MedTech Europe published its Guideline on how to understand the new framework regulation and its impacts on the medtech sector. Following the adoption of the Council’s General Approach, members gathered to assess impacts on the medtech sector stemming from recent scope changes. An analysis document has been shared with members in view of consolidating our further advocacy strategy for the announced trilogue under the Hungarian Presidency.
- One-Health: Following the joint statement of the five Agencies EMA, EEA, ECDC, ECHA and EFSA on how to deliver ‘Cross-agency knowledge for One Health Action’, the dedicated joint Task Force published its Joint Framework for Action for the period 2024-2026. MedTech Europe has approached the five agencies to seek clarification on how the Task Force envisages gathering and involving medical technology-specific expertise, input, data and information.
- PFAS: As the critical phase of declaring in-kind contributions to an envisaged IHI-PFAS topic call is on, we organised an information webinar and targeted Q&A session for interested members. The final list of industry participants and their estimated in-kind contribution to the project should be submitted to the IHI Office by the consortium no later than 26thSeptember. To allow the consortium to meet this deadline, we kindly request members to declare their estimated in-kind contributions to the consortium leader UCB without delay.
Besides, MedTech Europe commissioned EPPA to carry out a PFAS socio-economic impact assessment for medtech. The kick-off workshop was held on 24.07. Finally, we are delighted to report the launch of the first PFAS national workshop. Irish MedTech kindly hosted the national MedTech PFAS workshop on 12.07. in Dublin.
- Meetings convened: Microplastics TF: 03.07. ; Net-Zero Study SteerCo: 04.07., 18.07., 25.07.; Circular Economy WG: 10.07.; Drafting Team Green Deal Position: 15.07.; IHI-PFAS webinar: 18.07., 26.07.; Drafting Team UN Global Plastics Treaty: 19.07.; MTE PFAS SEIA Study Kick-Off Call: 24.07.; Drafting Team PPWR Guideline: 25.07.;
- We engaged at Irish Medtech Association’s QARA Forum: 11.07. and MTE and Irish Medtech’s PFAS workshop: 12.07.
Important dates to remember for the autumn:
- MedTech Europe Sustainability Face-to-Face meetings: 3/4 October, Brussels
- ENVI Council meetings: 14 October, 17 December
- Health Council: 9/10 October (informal), 3 December
- Competitiveness Council: 26 September, 28/29 November
- EP Committees: week of 2 September
- EP plenary: week of 16 September
