In May 2017, a new Medical Device Regulation (EU MDR) was established across the European Union (EU). Its objective is to validate the safety and efficacy of medical devices more thoroughly and proactively. This regulation will replace the existing Medical Device Directive (MDD). As a result, all medical device manufacturers will need to show evidence of a consistent and proactive process to document their pre- and post-market clinical research activities for medical devices of all classes.
EU MDR – What you need to know
Yet many manufacturers still feel overwhelmed by the requirements of the EU MDR. Our infographic offers you five practical steps to follow in preparing your internal processes for the Medical Device Regulation. The content, which is best viewed on your desktop or mobile device by the way, addresses five key areas you should be looking into to avoid having your medical devices and products being taken off the market, such as:
- Appointing a regulatory compliance expert within your organization
- Planning for more stringent audits, including unannounced ones
- Improving your PMS activities (including proactive PMS planning and reactive PMS vigilance)
- Reevaluating your devices with regard to technical files and UDIs
- Selecting a suitable, MDR-certified Notified Body before EUDAMED is launched
Above all, you will need a digital, standardized solution in place for your MDR-related activities, e.g. for conducting your clinical trials and post-market surveillance (PMS) and well as post-market clinical follow-up (PMCF) and technical documentation. Should you require support with managing automated and efficient post-market surveillance of your medical devices, drop us a line or arrange a free, personalized demo.
And if you want to take a look at the full MDR, the 175-page document can be found here.