If you sell medical devices in the European Union, they must meet the EU Medical Device Regulation (EU MDR 2017/745) and carry the CE mark. At MEDICA, ask every supplier for proof before you discuss price.
This is a short overview for buyers, not regulatory advice. Speak to a regulatory specialist about your own products.
What the EU MDR is
The EU MDR replaced the older Medical Device Directive. It sets stricter rules for technical files, clinical evaluation, labelling and tracking devices after sale. It applies to everything from a simple pair of scissors to complex equipment.
How surgical instruments are classed
- Reusable surgical instruments are usually Class Ir. The “r” means a notified body must check the reprocessing (cleaning and sterilisation) instructions.
- Non-sterile single-use instruments are usually Class I.
- Sterile instruments are usually Class Is. A notified body checks the sterilisation process.
The classification depends on the device and its intended use, so check each product.
Documents to ask for
- EU Declaration of Conformity for each product group
- Notified body certificate, where required (Class Ir, Is and higher)
- ISO 13485 certificate for the factory
- Instructions for use, including reprocessing instructions
- Labels showing the CE mark, manufacturer and UDI where required
- Name of the EU Authorised Representative
Your role as importer or distributor
Under the EU MDR, importers and distributors have their own duties. You must check that products carry the CE mark, have the right documents and are stored correctly. Keep records of what you buy and sell.
Ask Tata Surgical about compliance
Visit Hall 10, Stand C32 to see the documents for the products you plan to import. Our team will explain what we can supply for your market.
Looking for instruments like these?
Browse our catalogue or send us your drawing. We reply with prices, lead time and shipping terms.
