Compliance Consulting and Training, Diagnostic and testing, Medical Devices, Technology, Therapy Area

General Safety and Performance Requirements

By NSF International, Pharmaceutical Services

The heart of the European Union (EU) regulation of in vitro diagnostic medical devices (IVDs) lies in allowing market access to IVDs that offer clinical benefit, and are safe to the patient, the user of the IVD and others (such as service technicians).

The regulation is written so that requirements ensuring a high level of protection of health and safety are, where appropriate, must be fulfilled.

Under the EU IVD Directive 98 /79 / EC, manufacturers have been required to comply with the essential requirements (ERs).

Enter your details below to view the free white paper

By downloading this whitepaper, you acknowledge that GlobalData may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services.

Visit our Privacy Policy for more information about our services, how GlobalData may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.