How ISO 13485:2016 can help you comply with EU IVDR
Compliance with the new EU IVD regulation (IVDR) becomes mandatory in 2022. IVD medical device manufacturers can prepare by becoming certified to ISO 13485:2016, a key quality management system (QMS) standard that applies specifically to medical devices.
Accredited ISO 13485 certification from SGS is the first step on your regulatory compliance journey and lays the foundation for meeting your regulatory obligations.
IVDR Timeline and Process
What is IVDR and who needs it?
IVDR (EU) 2017/746, the new IVD medical device regulation, is a regulatory framework that replaces the current IVD Directive 98/79/EC. Legal manufacturers of IVD medical devices will need to comply with IVDR in order to use CE marking and gain access to the EU market.
An IVD medical device is a reagent, reagent product, calibrator, control, material, kit, instrument, apparatus, piece of equipment, software, or system that is used in vitro, alone or in combination, for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information for one or more defined specific medical purposes.
The IVD regulation defines a legal manufacturer as the natural or legal person who manufactures or fully refurbishes a device, or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark.
What is ISO 13485 certification?
This state of the art standard allows organizations to demonstrate their ability to provide medical devices and related services that consistently meet customer and regulatory requirements. Certification demonstrates compliance with the requirements of the new EU IVDR.
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How ISO 13485 Can Help with EU IVDR Compliance
Resources
ISO 13485:2016 - Journey to Regulatory Compliance for IVD Medical Device Manufacturers
