Our services regarding medical devices include:
- Authorized Representative service
- Registration with EU-Authority
- Certificate of Free Sales
- CE-marking consultancy
- Technical file preparation
- Notified Body guidance
- Clinical trial guidance
- Quality system implementation
All medical devices which are on the European Market needs to be CE-marked. By placing the CE-mark on a device, the manufacturer confirms that the product meets the requirements of the European Medical Device Directives (MDD 93/42/EEC, IVDD 98/79/EC and AIMDD 90/385/EEC).
The manufacturer, is responsible for the safety and efficacy of these devices.
Assessment for medium / high risk products:
A Notified Body assesses the conformity for medium and high risk medical devices (MDD: Class I sterile / measurement, Class IIa, IIb or III; IVDD: self-test, List A, List B; AIMDD: all). After the assessment, a CE-certificate will be issued to the manufacturer. The Notified Body will audit the manufacturer annually. Periodically, the Notified Body will perform unannounced audits. In duly substantiated cases, also the subcontractors or parties further in the supply chain can be subject to unannounced audits.