New EU rules set stage for procurement overhaul in medtech and diagnostics

The EU believes the changes could lead to as much as €3.3 billion per year in savings for medical technology firms across the continent, as it looks to ease the burdens created by excessive costs and development bottlenecks which risk creating uncertainty for manufacturers and delays for patients.

The Commission proposal (COM(2025)1023 final), unveiled on 16 December 2025, primarily concerns the revison of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). However, they will also have a significant impact on the procurement practices of companies across the EU. Accordingly, awareness and a thorough understanding of the changes – and how they could potentially affect stakeholders – is essential.

Under the proposed changes, the five-year limit on conformity certificates would be abolished, with an ongoing risk-based monitoring process taking its place. This would mean contracting authorities would no longer require a specific "remaining term", but would instead rely on a valid certificate alongside current proof of monitoring.

Also significantly changing are the requirements around permanent availability of person responsible for regulatory compliance (PRCC) figures, with general availability requirements being introduced – particularly for small and medium sized companies.  Assessment processes are being streamlined, with less mandatory requirements and more remote audits being introduced.

New classification rules will lower market entry barriers with more products – such as reusable surgical instruments and medical software – being recategorised as ‘class one’, which opens up greater competition in the market. Greater digitisation will also feature as part of the proposals, with online instructions for usage more broadly permitted.

Under the proposals, the European Medicines Agency will have a stronger role to bolster coordination between parties and provide greater levels of regulatory and technical expertise – along with monitoring shortages of medical devices. This will mean a list of critical shortages being created to ensure availability and patient safety.

Companies in the medical technology sector should already be making preparations ahead of the new rules being approved, to ensure they are ready for any potential impact the changes may cause them.

Updating procurement documents to take account of the relaxed rules around PRRCs and certification, and making digital evidence for documentation and reporting available, should be a priority.

The market, which already supports around a million workers across Europe, will see an influx of new supply opportunities and suppliers with the reclassification of products, and that could open the door to greater competition.

It also means reviewing contracts with existing or potential suppliers for any adjustments needed in the wake of the changes, and strengthening the security of supply chains, particularly in light of the EU’s new list of critical devices. 

Companies that are quick and reactive will be best placed to take advantage of the new rules from their implementation.