The new EU Medical Device Regulation (MDR) and the In vitro Device Regulation (IVDR) are expected to have a far-reaching impact for device manufacturers doing business in Europe.
Many in the medical device community are concerned about the implications of these pending regulations, which will require all existing devices to either be recertified or certified as new.
The United States has asked the European Union to delay implementation of both regulations by three years, citing “serious concerns” that it will impact access to the EU’s $125 billion medical device market. However, with the first deadline just nine months away, medical device manufacturers need to be taking steps now to prepare. Here’s what you need to know.
What Is The EU Medical Device Regulation and IVD Regulation?
The EU Medical Device Regulation is scheduled to take effect May 26, 2020, and will replace two existing regulations—the Active Implantable Medical Device Directive (AIMDD) and the Medical Device Directive (MDD).
The In vitro Device Regulation (IVDR) replaces the EU IVD Directive, which has been in place in Europe since 1998.
Together, these regulations will require more data-based evidence for new and existing medical devices. A few important requirements to note:
- Device manufacturers will be required to have risk management and quality management systems in place
- Manufacturers must continue collecting clinical evidence for all devices once they are on the market to demonstrate their safety and effectiveness
- Manufacturers must report data on a new centralized electronic system, and the data will be made publicly available
- Manufacturers are responsible for determining which devices will be reclassified and which will need further review by a notified body
- Manufacturers must have systems in place to cover their financial responsibility for harm caused by defective devices
The shortage of notified bodies creating bottlenecks in device approvals, the added burden and cost of meeting additional clinical data needs, and the potential for much needed medical devices coming off the European market are just a few of the challenges presented with this shift in requirements. It will no doubt be a difficult and costly change.
Complying With the New EU Regulations For Medical Devices
To navigate the complexities of this new change, companies are understandably turning to outside organizations for guidance and support, and organizations have released helpful resources to decipher the new requirements.
There is no magic wand to get companies to the other side of the new MDR and IVDR requirements without any bumps or bruises. Partnering with a medical device contract research organization (CRO) that can draw on their knowledge of this process, pull others in when needed, think strategically about cost-effective ways to gather sufficient clinical data, support sites, work on high-level interdepartment integrations, and be the calm through all of the chaos, can help situate companies for success in this new and evolving landscape.
So what do companies need from their CRO to ensure a good fit for assisting with the MDR and IVDR transition work?
Download the whitepaper for six characteristics that should be considered as a minimum set of requirements.