The European Union (EU) is bringing significant changes to their regulations related to medical devices and in vitro diagnostic devices. The new medical device regulations (MDR) and in vitro diagnostic device regulations (IVDR) represent a huge overhaul of the current certification process.
The new rules are being developed to “ensure a consistently high level of health and safety protection for EU citizens using these products.” (www.ec.europa.eu) Although there are some similarities to the newly adopted ISO 13485:2016 quality management systems certification requirements, the new EU MDR/IVDR include a number of significant differences.
The new MDR regulations are currently being reviewed by lawyers to remove any conflicting information, and are expected to be approved by EU Parliament in April of 2017, with an expected 3- to 5-year implementation period.
These new requirements will impact every medical device and diagnostic device company who sells their products in EU.
According to ECI-Rx Compliance Expert Brijesh Patel, “All manufacturers will need to re-certify all their products against the new regulations. As proposed, there will be “no grandfathering” of currently certified devices.” ECI-Rx can help navigate the complex flow of information review, audits, and testing needed to achieve certification.
A Brief Summary of the Pending EU MDR/IVDR Regulations
• More rigorous/consistent oversight of all medical devices
• More products will require pre-market Notifying Body (NB) review and approval
• Expansion of Eudamed (European Databank on Medical Devices)
• More resources for investigations/studies and maintenance of post-market documentation
Highlights of the New Regulations
- Redefining responsibilities
– Requires manufacturers to designate a specially trained “Single Authorized Representative,” similar to that of a ‘Qualified Person’ in the pharmaceutical industry
– Changes in flow of information to/from and the role of NBs in the certification process.
- A new, more detailed Essential Requirements Checklist that covers a broader scope, including:
– Safety and effectiveness of materials and interactions
– Risk management
– Risk / benefit ratio
– Post-market data
- Updated Classification Rules, which may lead to reclassification of certain non-invasive, invasive and active medical devices
– Special rules will apply to other types of devices
– Up-classification of in vitro diagnostic devices
- Stricter Clinical Evaluation requirements to produce more accurate, more detailed clinical performance data
– Scientific validity
– Analytical performance
– Clinical performance
- Increased expectations on the Post-Market Surveillance activities
– Required updates throughout the life cycle of the device supplemented with data obtained by post-market clinical follow-up
- Tighter Scrutiny Process
– Class III device manufacturers may voluntarily consult an expert panel on its clinical development strategy and on proposals for clinical investigations
- Expanded Information Access and Transparency
– The new Eudamed databank will allow access to patients, manufacturers, notified bodies and authorities.
Are You Ready?
“Early preparation is key,” notes Patel. “This is a critical time for MD and IVDD manufacturers. ECI-Rx’s compliance experts have worked hard to gain a full understanding of the new rules. By developing strategies and protocols for ensuring compliance, our team is already in a position to help manufacturers during this transition period to maintain or gain CE certification for their medical device products.”