In a medical setting, it is not only the high-tech equipment that makes a difference to positive outcomes. Non-active medical devices also have a crucial role to play and are held to equally high standards when it comes to safety and compliance. As a manufacturer of non-active medical equipment, you strive to fulfill the expectations of health care professionals as well as the authorities in charge of regulating your products. Our services can help you meet these expectations. With experts in the field active around the globe, we enable you to demonstrate the safety and reliability of the devices you manufacture, and at the same time to inspire confidence in your customers.
Notified Bodies are allowed to apply first-time since November 26, 2017 for designation under the Medical Device Regulation (MDR) 2017/745. We are glad to inform you, that our application is already filed and covers a comparable scope as currently maintained by us.
Commission Recommendation of 24th September 2013 on the audits and assessments performed by notified bodies in the field of medical devices (2013/473/EU) was published on 24 September 2014 and entered into legal force on 25 September 2013 by publication in the Official Journal of the European Communities.
Unlock your international success with our Market Access Services. To ensure a smooth and fast market access, we support you with all necessary certifications, inspections and regulatory researches.