Published in January 2026, the Dutch guideline treats medical technology as an organisation-wide, risk-based lifecycle process. Independent clinics should benchmark their controls against it.
The core of the guideline
The guidance by FMS, NVZ and UMCNL focuses on safe technology, competent users and safe application under the responsibility of specialist-care organisations. Its approach is process- and risk-based: higher risks call for demonstrably stronger controls.
Control the full lifecycle
Before purchase, define need, risks, conditions and total cost. Conduct risk screening and, where needed, prospective risk assessment. After technical and clinical release come use, maintenance, changes, incidents and controlled retirement.
- Investment plan and multidisciplinary selection.
- Risk classification and acceptance criteria.
- Technical and clinical commissioning.
- Maintenance, change control and periodic review.
- Retirement, data removal and traceable decision.
User competence
Connect authority and competence to the device and its use. Generic training may not be enough. Define who needs training, how competence is assessed, when refreshers apply and what happens after a relevant change or incident.
A 2026 gap assessment
Compare policy and practice for every lifecycle phase. Check not only documents but a sample of devices and users. Prioritise gaps by patient-safety risk and include actions in the annual quality plan.
- Is ownership clear at every phase?
- Do register, maintenance and incidents connect?
- Is clinical release evidenced before use?
- Is effectiveness of improvements checked?
Frequently asked questions
When was the guideline published?
The Dutch guideline database lists 21 January 2026 as its publication date.
Does it apply to independent clinics?
It covers medical technology under the responsibility of specialist-care institutions. Assess its application to your organisation and applicable supervision.
What is a useful first step?
Run a lifecycle gap assessment on one high-risk technology and use the findings to improve the wider process.
Official sources
- Leidraad Medische Technologie 2026
- Levensloop medische technologie
- IGJ — Toezicht medische technologie
This guide provides general information, not legal or medical advice. Always verify current official requirements for your circumstances.