Our products are medical devices and CE marked and not CE certified.
CE Certification for Class I Non-Sterile Products: For Class I, non-sterile medical devices, CE certification is not applicable. Instead, the responsibility for CE marking lies directly with the legally accountable manufacturer. This means the manufacturer must ensure that the product complies with all relevant safety, health, and environmental protection requirements outlined in European regulations.
Oversight and Supervision: In the Netherlands, the supervision of CE marking for Class I, non-sterile medical devices is carried out by the IGJ (Inspectie Gezondheidszorg en Jeugd), which is part of the Dutch Ministry of Health. This regulatory body ensures that manufacturers meet the necessary standards and maintain compliance with the applicable laws. Only higher-class medical devices, sterile devices, or those with a measuring function are required to be CE certified. In these cases, the certification process is performed by an independent Notified Body, which is responsible for assessing the product's compliance with European regulations.
Compliance with MDR (Medical Device Regulation): A CE-marked medical device signifies that it complies with the MDR (Medical Device Regulation, EU 2017/746), which is the binding European legislation for medical devices. This regulation covers everything from design and production to marketing and post-market surveillance. For customers outside of Europe, it's important to check the applicable regulations specific to your country, as medical device legislation may vary.
Declaration of Conformity: To provide formal proof that our EUROTAPE and SOMED branded products comply with the MDR, we can supply a Declaration of Conformity upon request. This document serves as official confirmation that our products meet all required regulatory standards under European law. By ensuring compliance with these strict standards, we guarantee that our products are safe, reliable, and meet the high expectations of our customers in both Europe and beyond.
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.
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.
Somed
Eurotape