Standards · Standard or regulation
EU MDR 2017/745
Regulation (EU) 2017/745 on medical devices
In plain words
What it covers.
The law that controls medical devices placed on the market in the European Union. Devices are classified I, IIa, IIb or III by risk, must meet the general safety and performance requirements, and most need a notified body to assess them before CE marking. It also strengthens clinical evidence, post-market surveillance, unique device identification (UDI) and vigilance.
Who uses it: Manufacturers, notified bodies, importers and distributors; hospitals making in-house devices or managing recalls.
A summary written by BMEssentia for learning, not the text of the standard. Always work from the current official edition and the manufacturer's instructions.
It covers
- Risk classification rules (Annex VIII)
- General safety and performance requirements (Annex I)
- Technical documentation
- Clinical evaluation
- Notified bodies and CE marking
- UDI and EUDAMED
- Post-market surveillance and vigilance
- Health institution exemption (Article 5(5))
Key points
What engineers need to know.
- Classes run from I (lowest risk) to III (highest), set by rules on invasiveness, duration and energy.
- Most devices above Class I need notified body assessment before CE marking.
- Manufacturers must run post-market surveillance and report serious incidents.
- Serious incidents must be reported within 15 days, or faster for serious public health threats or death.
- Article 5(5) lets hospitals make and use in-house devices under strict conditions.
- UDI lets a device be traced from factory to patient.
Devices
Devices it applies to.
Each device in the Medical City Device Lab, with its Device Library course on the Platform.
Medical City
Where you practise it.
- Design Studio regulatory pathway stage
- Commissioning incoming inspection (CE marking)
- S1-M183 regulatory change and in-house devices