EU MDR and EU IVDR published 0
Posted on 9, May 2017
in Category News
They are here. Long expected, hard debated and with major impacts for industry. The new European Regulations for Medical Device (MDR) and In Vitro Diagnostics (IVDR) are published on May 5, 2017. A new era has started.
This will affect all medical device manufacturers having currently device on the EU market: All devices will have to be recertified. No grandfathering option is included.
For the MDR, 3 years transition time is granted, for the IVDR, 5 years transition time is granted.
Even though that appears to be a long period, a closer look on the timelines shows that companies will have to start to prepare now:
– Are your devices newly classified? This can have a significant impact on your compliance
– Upgrade your QMS
– Assess meeting the new ER’s: General Safety and Performance Requirements
– Upgrade your technical documentation
In addition, companies should monitor the activities of the European Commission (EC) closely; Additional requirements will be defined by the EC and through implementing and delegating acts will be added to the now published text.
For planning your recertifications, one shall be aware of the fact that also the NBs will face a challenging period as well: Notified Bodies will have to be redesignated as NB under the new MDR through a joint inspection, including representatives of the EC . EC will publish the applicable designation product codes half a year from now, after which NB’s can start the redesignation process, which might take up to 2 years.
The Regulations identify new roles, resulting in more involvement and requirements for “new” economic operators like importer and distributors and also for Health Institutes.
What can you do? Start your preparation now! We can help you out with focused support on one or more of the new requirements, bring you in compliance, step by step. Do you want to find out more, get in contact or participate in our classroom training.