From MDD to MDR
A heavier evidence burden, carried further down the supply chain.
The Medical Device Regulation replaced the older Medical Device Directive across the European Union. The headline change is not the classification table — it is how much more of the file has to exist, stay current, and be produced on request. Technical documentation, traceability and post-market surveillance all became heavier, and notified bodies became far more involved in routes that used to be largely self-declared.
For a manufacturer of hand instruments, most of that weight lands in places a buyer never sees: how a batch is identified, what is recorded about the steel it came from, and whether the paperwork for a shipment can still be reconstructed years after it left the workshop. That is the part we build for.
Our position
What you can expect from us
Documentation that survives the order
Certification, packing and export paperwork prepared for the market you are shipping into, and kept so it can be produced again later.
Inspection recorded, not assumed
Every piece is held and closed by a person before it leaves. The check is part of the process, not a sample taken at the end of it.
Built to your specification
We work to your drawing, sample or pattern, and agree tolerances before anything is forged — so what arrives is what your file describes.
Annex VIII
Device classes at a glance
Where a device sits decides the conformity route. Most reusable hand instruments fall in the lowest class; the rest is here so you can place your own product.
| Class | Risk | What falls here |
|---|---|---|
| Class I | Low risk | Non-invasive and simple hand-held instruments. Most reusable surgical instruments sit here, with reusable surgical instruments handled as the Ir sub-class. |
| Class IIa | Medium risk | Devices used transiently or short-term inside the body, and instruments supplied sterile. Requires a notified body in the conformity route. |
| Class IIb | Medium to high risk | Longer-term invasive devices and implantable components, with correspondingly heavier clinical evidence and surveillance obligations. |
Summarised for orientation only. Classification for your own device is determined by the regulation and your notified body, not by this page.
Need specific documentation for your market?
Tell us where you are shipping and what your file has to contain, and we will tell you exactly what we can supply with the order.
Ask about documentation