Transitioning Like a Pro to the EU MDR
Transitioning as seamlessly as possible to the new MDR involves implementation of three concepts: preparing for the transition without delay, understanding major points of change in the MDR and effectively adhering to compliance regulations to avoid disruptions. By shifting regulatory focus from the pre-approval stages covered extensively in the Medical Device Directive (MDD) to the complete life cycles of products, the MDR aligns closely with several other international standards, including standards recognized by the U.S. FDA. This change, in general, will authorize more rigid interpretations by the industry as well as by Notified Bodies.
Important Themes of the EU MDR
Greater Emphasis on Evaluations of Clinical Trial Data
A smooth transition from the MDD to the MDR involves focusing on the challenge to unequivocally demonstrate safety and performance criteria for medical devices. Clinical data results will be more closely evaluated and leave no room for ambiguous or insufficient data.
Stricter Supervision of Notified Bodies
Although the MDR describes enhanced supervision of NBs, it is not yet known whether potential sanctions against NBs in violation of compliance regulations may be established against the judgment of Member States. However, the new rule states that qualification requirements for reviewing and auditing NBs will be substantially increased.
Clinical Investigations Expected for Class III Implantable Devices
In general, NBs cannot acknowledge the equivalence approach according to new MDR rules, with a few exceptions. For example, requirements of clinical investigation do not apply to medical devices lawfully put on the EU market in accordance with the MDD and the AIMDD where such products demonstrate conformance based on applicable Common Specifications and ample clinical data.
Things to Note About the New EU MDR Before Developing a Transition Plan
Weighty changes in the way the MDR is worded will demand organizations rationalize portfolios and conduct globally meaningful impact assessments so they can successfully implement changes essential for remaining compliant.
The MDR (Annex I), identifies and defines new conditions that need to be addressed for the majority of legacy devices. All existing devices must be or ‘eventually will need to be) recertified according to new regulations.
Transition strategies should also focus on changes to Unique Device Identification rules. New UDI regulations are meant to improve tracking of products throughout economic operator supply chains. In addition, all labels must carry UDI information.
Companies should be aware that the definition of a medical device has been expanded to include many cosmetic and non-medical products unregulated by the previous MDD. This means a company undergoing the transition should revisit and analyze core processes that include but are not limited to risk management, post-market expectations and quality assurance protocols. All require diligent review, updating and planning to re-implement them in compliance with MDR regulations.
Primary project coordinators under guidance from steering committees can organize project-specific teams and streamline workflow to accomplish transition goals. Functional area departments may include operations, quality, supply chain, regulatory and legal. Teams should be responsible for developing up-to-date documentation, revising/creating procedures and other pertinent tasks under the direction of quality management personnel.