Understand how to implement the EU MDR
The European Union (EU) Medical Devices Regulation (EU 2017/745) (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU 2017/746) (IVDR), now apply. Important terms used in the regulations are ‘entry into force’ and ‘date of application’. The publication of the text in the Official Journal of the European Union was on 5 April 2017. The ‘entry into force’ was the date when each regulation came into effect, twenty days after publication. The ‘date of application’ reflects the date from which the requirements apply and the Active Implantable Medical Devices Directive (AIMDD - 90/385/EEC), Medical Devices Directive (MDD - 93/42/EEC) and In Vitro Diagnostic Medical Devices Directive (IVDD - 98/79/EC) were repealed.
Take advantage of our free medical device whitepapers
Our white papers will help you understand how to perform better, reduce risk and make excellence a habit in your organization. See below some examples of other available whitepapers.
- The Differences and Similarities between ISO 9001:2015 and ISO 13485:2016
- EUDAMED: an overview of how it is being developed and deployed by the European Commission
Interpret and implement standards and regulation with ease
BSI Compliance Navigator is the only platform designed by regulatory experts to help manage your medical device compliance, all in one place. Access thousands of standards and regulations, from MDR and IVDR to MDSAP requirements, we have you covered.
What's more, Compliance Navigator will alert you of any upcoming changes to relevant standards and regulations, meaning you can prepare, far in advance. Use our Tracked Changes to see what's changed quickly and efficiently, followed by our Expert Commentary to help interpret and implement with ease. Save time, reduce risk and unlock market access with Compliance Navigator.
