Are You Ready for the In Vitro Diagnostic Medical Device Regulation (IVDR)?
Any IVD medical device not complying with In Vitro Diagnostic Medical Device Regulation (IVDR) (EU) 2017/746 by the date of application on May 26, 2022, following the transitional provisions in Article 110 of the IVDR cannot further be placed on the EU market.
Among the huge regulatory changes from the IVD Directive 98/79/EC (IVDD) to the IVD Regulation 2017/746 (IVDR), manufacturers that could previously self-declare conformity (as many as 80%) now require a conformity assessment by a notified body. The IVDR has also placed a greater responsibility on manufacturers as well as an increased demand on designated notified bodies.
If you haven’t fully prepared for the IVDR, you must act now!
As the date of application of the IVDR draws closer, many manufacturers are struggling with the minefield of preparing technical files. To help assess your stage of the journey, consider these questions:
- Have you completed performance evaluations of all your devices?
- Does your quality management system (QMS) comply with the additional IVDR requirements or only with ISO 13485?
- Is your UDI system going to be in place before your first audit?
- Does your risk management follow the requirements of the IVDR.
- Is it too late for you to engage with a notified body?
We can support you with training, consulting, preparation of technical files, technical file remediation, performance evaluation reports and more.
Check out our handy resources to get started.
Videos
Are You New to the IVD Industry?
Listen to Sarah Moore, Director of Medical Device and IVD Consulting, for practical advice on what the DoA means for manufacturers new to the IVDR.
IVD Advice for Experienced Manufactures
Listen to Dr. Peter Wirthschaft, Senior Manager for IVD Consulting, EMEA, for practical advice that goes beyond the basics.
Webinars
White Papers
Report: EU IVDR State of the Industry 2021
MedTech Summit and NSF conducted a huge survey of medical device and IVD professionals to discover the industry’s readiness for the IVDR.
Your Free EU IVD Regulation Readiness Health Check
Take our “health check” to assess your EU regulation readiness, the first step for putting things in order.
GSPRs (General Safety and Performance Requirements): The Heart of the EU IVDR
This white paper compares the essential requirements (ERs) described in the EU IVD Directive with the general safety and performance requirements described in the new EU IVD regulation.
Articles and Brochures
Navigate the Regulations for In Vitro Devices
Find out about the full import of the new rules and how NSF can help original equipment manufacturers deliver fully compliant IVDs.
In Vitro Diagnostic Services
Learn more about NSF’s IVD services, including consulting, auditing and training throughout the product lifecycle.
