Competitiveness

The sector filed more than 15,900 European patent applications in 2025, close to double the number filed in pharmaceuticals, and a higher share of them were granted: 77% against 39%. Over the past two decades medical technology filings have almost tripled, while pharmaceutical and biotechnology filings stayed flat. There is no patent cliff here and no exclusivity period. Products are improved, replaced and improved again. 

Europe has more than 36,000 medical technology companies and around 90% of them are SMEs, most employing fewer than 50 people. When regulatory cost goes up, a large company reallocates. A small one stops making a product, drops a product line, or closes. What disappears is often an orphan device, and nobody else picks it up.

More than two million medical technologies are in use across Europe, from wound dressings and syringes to implants, scanners and diagnostic tests. Hospitals depend on the ordinary ones every single day. A competitiveness policy tuned only for novelty misses most of what care is actually made of. 

• An end to fixed recertification: Open-validity certificates with risk-based checks would replace the fixed five-year cycle. Recertification largely repeats work already done through annual audits and post-market surveillance. Removing it lets regulators focus where the risk actually is, not where the calendar says.
• A legal basis for international cooperation: The Medical Device Single Audit Programme already lets one audit satisfy five jurisdictions, including the US, Canada and Japan. Europe remains an observer, not a member. Fixing that cuts duplication and makes the CE mark count for more abroad, which matters most to smaller companies that cannot afford five separate audits.

• Include children: The new breakthrough and orphan pathways are a genuine step forward, and Europe is the last major jurisdiction without them. They should cover paediatric devices explicitly. Not every device made for children is rare or breakthrough, and children should not wait longer than adults for the same technology.
• Treat cybersecurity as cybersecurity: A security event that harms a patient is a safety matter and belongs in the vigilance system. A vulnerability that harms nobody is not. Running both through one channel merges two frameworks that use the same words differently, helping neither patients nor regulators.
• Put AI requirements inside the framework, not alongside it: AI-enabled devices are already regulated under the MDR and IVDR. The AI Act’s high-risk requirements should sit within those rules, so manufacturers face one conformity assessment, not two overlapping ones. This is not deregulation: the safeguards stay, the duplication goes. Aviation already works this way.

Reusable by default: The Commission proposal would presume that devices are reusable unless a manufacturer justifies designating them single-use. Most single-use devices cannot be reused, and the single-use principle exists because of what happened in the past when they were. The Commission’s own 2024 study found the evidence on the safety of reprocessing is thin, and recommended developing guidance on which devices are suitable before going further. No other major jurisdiction takes this approach. 

• One rulebook for Europe: Procurement markets are still divided along national lines, and a directly applicable Regulation is the instrument capable of closing that gap. Suppliers would prove their eligibility once, digitally, rather than reassembling the same file for every tender in every country. 
• Value over lowest price: Best quality for public money becomes a principle of EU procurement, and price-only awarding is no longer available. Price alone undervalues what a technology does for a patient and what it saves a health system over time. 
• A real route for innovation: A dedicated innovation procedure, available without first running and failing a standard tender, that ends in a contract for deployment rather than a pilot. 

• Make quality decide: At a 30% minimum weighting, price can still decide the outcome, and the text leaves buyers routes to step outside quality assessment altogether. The floor should rise, the exits should be narrowed, and life-cycle costing should move towards total cost of care along the patient pathway. 
• Required, not optional: Market consultation, division into lots and variant offers are all available, but almost none of them is required. Tools a buyer can skip get skipped. Where a level playing field is the aim, common requirements work better than enabling language. 
• A way in for smaller companies: Buyers should explain when they choose not to divide a large contract into lots, and payment terms should be enforceable, with a firm maximum and interest for late payment. A contract won and paid late is a cost carried, not a market opened. 
• Resilience, proportionately: Recognising health as a critical sector is the right starting point, and security of supply matters directly to patients. Requirements need to be proportionate, based on evidence and workable for suppliers, with a coordinated approach across Member States rather than separate information requests in each. Resilience is built across a whole supply chain. It should not be loaded onto a single buyer or a single bidder. 

• Measure what is actually European: MedTech Europe welcomes keeping European preference voluntary and aligned with the EU’s trade commitments, but how origin is measured needs a rethink. The proposal relies on a customs test of where a product was last substantially transformed. Yet much of medtech’s European value sits in research, design, certification, installation, maintenance, training and clinical support, and a test based on final assembly misses most of it. It also risks ruling out technologies patients need, in a sector built on globally sourced components. Any preference should be targeted and proportionate, applied only where competition and supply are secure, and should never put continuity of patient care at risk.