Good news for hospitals, distributors, and manufacturers across Europe.
On 16 December 2025, the European Commission published a landmark proposal to simplify the EU Medical Device Regulation (EU MDR 2017/745). For those of us who manufacture and supply reusable surgical instruments, this is the most significant regulatory development since Brexit.
What's Changing?
The proposal (COM(2025) 1023) recognises what many in our industry have known for years: the current EU MDR requirements are disproportionate for lower-risk devices like reusable surgical instruments.
**Key changes for reusable surgical instruments:**
The Commission proposes that classification rules should be adapted to reflect the actual risk of devices, resulting in **lower risk classification for reusable surgical instruments**.
Most significantly, the proposal states:
"Where the manufacturer of class I reusable surgical instruments has applied harmonised standards or common specifications covering all relevant aspects... the involvement of a notified body is not required."
In practical terms, this means manufacturers who follow harmonised standards (such as EN ISO 17664 for reprocessing instructions) would be able to self-certify their reusable surgical instruments — similar to how things worked under the previous Medical Devices Directive.
Why This Matters
Since the EU MDR came into full effect, reusable surgical instruments have been classified as Class Ir, requiring Notified Body assessment for reprocessing validation. This created significant costs and delays, particularly for smaller manufacturers and niche products.
The evaluation accompanying this proposal found that overly complex requirements have led to:
- Reduced availability of certain devices
- Negative impacts on innovation
- Disproportionate burdens on SMEs (who make up 90% of the medical device industry)
- Higher costs passed on to healthcare systems
What Happens Next?
This is a **proposal**, not yet law. It must pass through the European Parliament and Council before becoming regulation. However, the direction of travel is clear — the Commission, Parliament, and multiple Member States have all called for simplification.
The proposal also includes:
- Reduced administrative burden across the board
- Streamlined certification procedures
- Fee reductions for SMEs (50% for micro enterprises, 25% for small enterprises)
- Better coordination between national authorities
What This Means for Our Customers
At Scala Surgical, we've been manufacturing surgical instruments since 1923. We've navigated every regulatory change from the original Medical Devices Directive through to today's EU MDR.
**For our EU customers:** We already offer full EU MDR compliance through our certified distribution partners. If this proposal passes, the pathway to supplying you directly will become significantly simpler.
**For our UK customers:** Nothing changes — we remain fully UKCA compliant and continue to supply the NHS and private healthcare providers across the United Kingdom.
We'll continue monitoring this proposal as it progresses through the legislative process and keep you informed of any developments that affect your supply chain.
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Have questions about EU MDR compliance or sourcing surgical instruments?
We're always happy to discuss how regulatory changes affect your procurement.
References
- European Commission Proposal COM(2025) 1023 final, 16 December 2025
- Regulation (EU) 2017/745 on medical devices (EU MDR)