Inside EU Health: Medical devices; Irish Presidency; CMA

Schenk pushes for simpler EU medical devices rules

MEP Oliver Schenk (EPP, Germany) has urged the European Parliament to back a faster, more predictable and less burdensome medical devices regime, while keeping patient safety at the centre of the revision.

Presenting his draft report, Schenk argued for mandatory timelines, a more risk-based system, lighter administrative requirements and stronger support for SMEs. He said the sector was not a “niche branch”, with the EU producing around 500,000 devices amounting to €170 billion in turnover. 

MEPs broadly welcomed his report, but with some concerns. Jessica Polfjärd, (EPP, Sweden), said requiring manufacturers to justify why a product is single use could create “unnecessary administrative burden”, particularly where hygiene and patient safety are decisive. She said she would table amendments to preserve the current approach under Article 17. 

Artificial intelligence was another fault line. MEP Maria Guzenina (S&D, Finland) from the Internal Market Committee (IMCO) cautioned against fragmenting the AI Act and creating duplicate rules for AI-enabled medical devices.

Carroll MacNeill tells MEPs she’s putting competitiveness and access at heart of Irish Presidency

Irish Health Minister Jennifer Carroll MacNeill told MEPs on the Public Health (SANT) Committee that Ireland's EU Presidency will focus on linking competitiveness with better patient access to medicines, placing the Biotech Act and the medical devices revision at the top of its agenda.

Asked about Trump’s ‘Most-favored nation’ policy, she said: "On the MFN question... It is a huge priority. It's really important," Carroll MacNeill said the issue had already been discussed by EU health ministers in Luxembourg and that the European Commission was preparing further analysis.

She said the clinical trials chapter of the Biotech Act was their top priority. "We want people in Europe to have much better access to clinical trials," she said.

The Presidency will also host initiatives on workforce resilience and women's health, including a dedicated conference on endometriosis.

Pressed by MEPs on health commitments in the future of the EU’s long-term budget, the minister said that she would not be addressing budget issues.

Carroll MacNeill tells MEPs she’s putting competitiveness and access at heart of Irish Presidency

Irish health minister tells MEPs she is focused on competitiveness and better access to medicines and medical devices

Vital SignsCatherine Feore

MEPs give Critical Medicines Act final committee green light ahead of November plenary

The European Parliament's Public Health Committee (SANT) has approved the provisional interinstitutional agreement on the Critical Medicines Act. Committee Chair Adam Jarubas confirmed that the agreement will now undergo legal-linguistic revision and translation before Parliament formally adopts its first-reading position, expected during the second plenary session in November. 

Rapporteur Tomislav Sokol (EPP, Croatia) singled out the Act's new collaborative procurement mechanism, saying it will allow member states to "strengthen their bargaining position" when negotiating with industry, ensuring patients in smaller markets can access medicines "much faster and with a better price." He described the measure as "a good sign of European solidarity," enabling less advantaged regions to benefit alongside wealthier member states. 

It is hoped that the CMA will reduce medicine shortages, boost EU pharmaceutical manufacturing and lessen strategic dependence on imports from China and India.