No matter your role in the industry, you may have heard about the significant upcoming changes to European medical device regulations. But just what are they? What’s the proposed implementation timeline? Here’s an overview of the proposed legislation, as well as a tentative schedule of important dates.
Getting Up to Speed
In June 2016, the European Union issued proposed changes to its Medical Device Directives, publishing a near-final draft of the new European Medical Device Regulations (MDRs). While the final drafts have not yet been released — their anticipated completion date is in March 2017 — their fundamental principles are unlikely to have significant differences. If so, the adoption process will likely occur in May 2017.
The bottom line? Medical device manufacturers intending to bring their products to the European market will need to alter some of their development strategies to navigate these new pathways.
Why Make These Changes Now?
These alterations to existing laws in the EU are largely coming as a response to a widespread demand for increased patient protections — and for good reason. In the past, high-risk devices, such as implants, have, on average, underwent significantly shorter approval processes compared to the United States. However, this expediency may have come at the price of patient health and well-being: There has been a correlation between medical devices that are first approved for European markets and greater safety issues. Some specific high-profile cases that have influenced the push for reform include Poly Implant Prothèse (PIP) breast implants and metal-on-metal hip replacements.
As a result, existing regulatory standards in the EU have received heavy criticisms over the last few years. MDR has been designed to address them.
New Regulations for the EU
The new EU regulations are addressed in two major documents: the European Medical Device Regulation (MDR) and the European In Vitro Diagnostic Regulation (IVDR). The MDR will cover devices that previously fell under the Medical Device Directive and the Active Implantable Medical Device Directive and will have a three-year transition period. The IVDR will cover devices previously regulated by the In Vitro Diagnostic Directive. IVDR’s longer five-year transition period is because of the less-comprehensive information found in previous regulations.
Changes for Notified Bodies
One major aspect of these MDRs is the more demanding requirements for Notified Bodies (NBs). This includes a stricter accreditation process: Current NBs must be re-certified under the new standard. Additionally, NBs must perform unannounced manufacturer and supplier audits as part of their role in oversight.
Stricter regulations for NBs has been an ongoing trend in the EU. Consequently, there’s been a decline in the number of NBs operating in the region. Implementation of MDR is likely to result in additional strain for existing NBs and the need to establish new ones.
Increased Demand for Clinical Evidence
A second significant change will be to the level of clinical evidence necessary to support medical device assessment. Implants and all Class III devices must undergo clinical investigations, and demonstrations of equivalence will no longer be accepted. There will also be a requirement for increased documentation, with a Clinical Expert Report that covers the product’s entire life cycle. The MDR also places a greater emphasis on comparative device evaluation.
Clarifying Regulatory Requirements for In Vitro Diagnostic Devices
IVDR will introduce a new risk-based classification system for IVDs, ranging from Class A (lowest risk) to Class D (highest risk). NBs must participate in the evaluation of Class B and higher devices. Additionally, Companion Diagnostics will be regulated for the first time under IVDR, and competent authority involvement will be required.
Learn more on this topic by watching our latest webinar, Medical Device Regulation: Finding Your Path to Success.