Compliance with European regulations has become progressively more complex. And to help you understand what your responsibilities and requirements are the Norway Health Tech Academy is offering a breakfast webinars series to review many of these complexities..
Medical devices and In Vitro Diagnostic medical devices (IVDs) have a fundamental role in saving lives by providing innovative healthcare solutions for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease. To align with sectorial developments over the last 20 years, the EU has revised the legal framework governing medical devices and in-vitro diagnostics. The new regulations will come into effect on 26th May 2021 for MDR and 26th of May 2022 for IVDR*.
The changes are many in the MDR compared to the MDD, so we decided that in order to give our members the upper hand we needed to break it down and offer specialized courses on some of the major changes.
So therefore, the Academy is launching a series of 5 breakfast webinars starting on August 19th focusing on different topics each time – we call it “Gearing up towards MDR”. Together with our partner Obelis, we invite you to attend one or all webinars this fall. We will address important issues like early phase strategy, classification, technical documentation and clinical evaluation.
New role within your organization
Also – a new role has been created in the MDR, called the Person Responsible for Regulatory Compliance (PRRC). Article 15 of the European MDR and IVDR mandates the appointment of this person by manufacturers of medical devices. Very short – here are the main responsibilities of the PRRC:
- Check conformity of devices with QMS procedures before they are released
- Make sure all Technical Documentation and Declarations of Conformity are up to date
- Ensure all postmarket surveillance and reporting obligations are met
In order to fill this role, you need to know all that that entails not only for your organization but for the person appointed to be your PRRC. We are launching a 2 x 3 days training in January and February, with an overview of the PRRC on December 15th, the last of the 5 webinars. During this training you will have access to many experts specializing various aspects of the regulations. You will also be able to get answers to practical questions you have about your products and how to comply to the regulation.
The webinars and trainings are open for everyone. We have three pricing levels: 1 Norway Health Tech members, 2 Members of other clusters/incubators, 3 Public (non members).
For more information and registration:
2020 – the Regulatory Breakfast series – Gearing up towards MDR:
- 19. August 08.30-10.00 :Regulatory breakfast: Early phase strategy
- 8. September 08.30-10.00 :Regulatory breakfast: Classification
- 13. October 08.30-10.00 : Regulatory breakfast: Technical documentation
- 24. November 08.30-10.00 : Regulatory breakfast: Clinical Evaluation
- 15. December 08.30-10.00 :Regulatory breakfast: PRRC intro (Person Responsible for Regulatory Compliance)
- 2021 – Training for PRRC (Person Responsible for Regulatory Compliance)
- – 21. January 09.00-17.00 :Academy: PRRC Workshop Beginners
- – 18. February 09.00-17.00 : Academy: PRRC Workshop Advanced
If you have any questions, please don’t hesitate to ask us – contact our regulatory advisor Kami Faust
*Source: https://ec.europa.eu/health