REGULATION
MDSAP, and the use of MDSAP certificates for CE marking purposes, is essential to capture the full benefits of reliance and increase the atractiveness of the EU market.
Strengthen: targeted improvements needed
The Commission’s proposal rightly addresses many structural challenges. In several areas, however, the legislative text does not yet fully deliver on the proposal’s own stated ambition. MedTech Europe proposes targeted improvements to ensure it delivers in practice what it promises on paper. The proposed breakthrough and orphan device pathways need refinement in two areas to realise their full potential: 1. Paediatric inclusion: paediatric devices should be explicitly included in the scope of Article 52a MDR, ensuring that all children benefit from adapted assessment pathways.
2. Align IVD orphan devices with rare diseases: the proposed IVDR threshold of 1 in 12,000 individuals per year risks excluding diagnostics for rare conditions. Aligning the definition with the established European threshold for rare diseases (5 in 10,000) also would bring needed coherence with the orphan medicinal products framework.
Two distinct cybersecurity scenarios require different regulatory responses: patient safety incidents should follow established vigilance reporting channels, while vulnerability disclosures must allow manufacturers time to develop patches before disclosure. Inclusion of AI requirements into a single MDR/IVDR conformity assessment process is the right approach. To bring legal clarity, a time-bound process to reflect AI Act requirements should be included in the legislation. Routine blood draws and finger-pricks
are safe, well-established procedures. Yet under the current framework, they are treated as having the same risk as biopsies or spinal taps. MedTech Europe proposes amending Article 58(1) IVDR to clarify that full authorisation requirements are triggered only where the invasive procedure poses a major clinical risk to subjects. Where a CE-marked device is available
for the same purpose as a laboratory- developed test or other device, the CE-marked device should be used as the standard.
Rethink: reprocessing of single- use devices
The Commission’s proposal shifts the regulatory default: devices will be
Every month without simplification is a month in which manufacturers continue to redirect investment away from Europe, patients face
avoidable disruptions to the technologies they depend on, and the EU falls further behind
presumed reusable unless manufacturers justify a single-use designation. This is a departure from the current MDR framework and from every other major jurisdiction.
Under the current MDR (Article
17), reprocessing of single-use devices is permited only where national law allows and in compliance with common specifications. The proposal reverses this logic: manufacturers must now justify why a single-use device cannot be reused; or it becomes a reusable device and the manufacturer must add reprocessing instructions. The evidence does not support this shift. The Commission’s 2024 study on reprocessing and reuse of single-use devices highlights evidence gaps regarding safety and effectiveness of reprocessing, and recommends developing guidance on which single-use devices are suitable for reprocessing, recognising that not all are appropriate. The single-use design principle is grounded in patient safety: a lesson learned from serious historic incidents, such as the HIV transmission risks in the 1990s. Most single-use devices cannot be reused, and the proposal places a heavier burden of proof on manufacturers without addressing this reality. MedTech Europe’s position: Reprocessing of single use devices should not be the regulatory default. These devices are specifically engineered for single-use, and that design choice is integral to their safety and performance profile. The European Commission’s proposal should be rebalanced to ensure that there is no burden on manufacturers to justify that devices which are single-use only cannot be reused. This otherwise places an unfair and unrealistic burden on the vast majority of single-use devices which could not be reused. Devices designated as single-use only will have clinical data supporting that status; such data would not be expected to address, for example, the risk of infection from reuse. The Commission’s proposal does not consider patient safety risks from
reuse (since their proposal focuses on physical characteristics of the device). Risk management should be taken into account in determining the indication for single-use only. The changes proposed by MedTech Europe clarify that devices should be ‘single-use only’ where the manufacturer has performed a risk management analysis including the risks from re-using the device. The burdensome and unclear requirement for a justification is removed and manufacturer obligations are clarified. Where single-use devices are fully refurbished, MedTech Europe supports clear assignment of manufacturer responsibilities to the full refurbisher. Labelling and traceability of the fully refurbished device should be ensured. Clear responsibility supports patient safety and ensures that risks from off- label use of the fully refurbished device are taken into account.
Conclusions The Commission’s proposal provides a solid basis for reform. With targeted refinements on predictability, proportionality and support for innovation, the EU can build a regulatory framework that gets safe technologies to patients faster, strengthens health systems and restores Europe’s position as the destination of choice for medical technology development. A simpler, more predictable system is not a shortcut on safety. It is the condition for safety, for patient access, and for Europe’s long-term competitiveness.
MedTech Europe is the European trade association for the medical technology industry including diagnostics, medical devices and digital health. Its members are national, European and multinational companies as well as a network of national medical technology associations that research, develop, manufacture, distribute and supply health- related technologies, services and solutions.
publicaffairs@medtecheurope.org www.medtecheurope.org
August 2026
WWW.PATHOLOGYINPRACTICE.COM 49
PPi
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56
