European Union confirms the adoption of the EU medical device and in-vitro diagnostic regulations.
If you have regulatory responsibility for medical devices and in-vitro diagnostic products in Europe please take a moment to absorb this critical message...
The regulation is now here, plan for your companies transition and demonstrate your new knowledge of the requirements and impacts by attending our EU medical device courses available in public venues or in-company.
https://www.regonline.com/builder/site/Default.aspx?eventid=1968348
As a company you have likely experienced the negative shift-change in the speed to get both a CE certificate renewal and how hard it is to get a notified body assessment for a new product. That problem is set to increase dramatically as more is understood about the regulation.
Notified Bodies are significantly investing in recruiting and training regulatory and technical people in order to address current demand.
This situation requires stragic thinking and HR planning.
Now is a good time to prepare your narrative to your senior management and define the ACTUAL problem statement that your business now faces.
Please begin to make positive plans that will address...
- Awareness and qualification of your QARA people to address the new EU regulatory framework and requirements.
- Advising your Senior Management about the most immediate priorities to get to and stay on the EU market
- Evaluating your current product portfolio and determining critical gaps
- Establishing the facts that enable you to forward plan
Please read the attached information brochure and if you want to discuss or require guidance, at NSF we are here to help.
https://www.nsf.org/newsroom_pdf/md_regs_prepared_impact.pdf
The changes in the medical device regulatory framework is going to hit harder than you think and much earlier..
Be prepared for the impact
Medical Device Regulatory and Quality System professional
7 年it is my understanding the main impact is to the CER, the risk class elevation of products and the mysterious Review Board. Am I missing any other key points?
James Pink Well said. We are in times that require solid RA/QA and R&D knowledge management for sure.
Founder at PharMedTech & TriuneTechnologies / Pharmaceutical / Medical Device / Digital Health / Applied Technologies
8 年The changes in the medical device regulatory framework are significant and the expectations are higher with many organisations having to do more than the current practice to comply with the requirements. The reliance on extra resources will be key.