Services for In-Vitro Diagnostic Devices
For the detection of disease, infection or other health conditions, in-vitro diagnostics are used both in professional medical settings and by consumers at home. The reliability and safety of these products is your company’s top priority as you strive to compete in the health care market. With our services and top-notch staff of specialists, you can meet compliance demands while boosting consumer confidence in your brand. Partnering with our experts gives you access to our state-of-the-art laboratories, know-how and unparalleled experience.
Application for designation under the Regulation for In vitro Diagnostica (IVDR) 2017/746
Notified Bodies are allowed to apply first-time since November 26, 2017 for designation under the Regulation for In vitro Diagnostica (IVDR) 2017/746. We are glad to inform you, that our application is already filed and covers a comparable scope as currently maintained by us.
Unannounced audits
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.
New Regulations for Medical Products
Market Access Services
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.
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