Quality Management
Almost all EUROTAPE and SOMED branded products are CE marked.
The products without CE marking are:
✓ non-sterile products with antimicrobial adhesives
✓ products used different from the intended use (e.g. OP-Film for adhering sensors)
✓ products that are NOT added to a surgical package, e.g. folded incise film in a wrapper
The responsibility for CE marking or CE certification of these products lies with our customer.
Our products are medical devices and CE marked and not CE certified.
Only higher class medical devices, sterile devices or devices with a measuring function must be CE certified. This is performed by a Notified Body.
A CE marked medical device complies with the MDR (Medical Device Directive (EU) 2017/746). This is the European legislation for medical devices. Outside Europe, other legislation applies. Check which legislation is valid in your country.
Our Declaration of Conformity is available upon request as proof that EUROTAPE and SOMED branded products comply with the MDR.
The party responsible for CE marking is normally the company that brings the finished end product to the market, i.e. a product that is immediately suitable for end use in operating theaters.
Products manufactured by Eurotape BV are an exception to this. Our products are not ready for end use, actually they are semi-finished products, but CE marked! All our products are intended to be used in combination with a surgical drape or can be added to a surgical package or set. This makes our products fall under Article 22 of the MDR.
This article deals with systems and treatment packs and applies to the products (surgical packs or sets) that our customers assemble, sterilize and put on the medical device market.
A custom procedure packs manufacturer who assembles a surgical kit with CE marked or certified products must ensure that:
1. the products being put together are mutually compatible (compatible), for example, that the tape adheres well to the cloth;
2. the products are used in accordance with their intended use, e.g., a tape for attaching a cloth to a patient;
3. relevant information is provided to users, i.e. the information contained in the instructions for use, e.g. that the skin should be dry; and
4. the combination is subject to appropriate methods of internal monitoring, control and validation; and
5. sterility has been ensured;;
6. the sterilization method has been applied in accordance with the manufacturer's instructions.
If a product without CE is added to a surgical kit, then the organizer of the surgical kit takes over the responsibility for the CE marking and must provide the corresponding technical documentation and prepare its own Declaration of Conformity.
Eurotape BV has prepared technical documentation for all product groups to proof our CE marked products comply with the MDR.
Somed
Eurotape