Europe – Regulatory Strategies for EU MDR and IVDR Implementation

September feature articles took an in-depth look at the new EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), where global medical device leaders explored the nuances of the new requirements and answered the industry’s most challenging questions. Individual articles covered the implementation of the regulations into national legislation, what the new regulations mean for substance-based medical devices, how to incorporate clinical evaluation requirements into the design and development process, challenges in clinical evaluation for the EU versus China, contractual and QMS-driven implementation of shared economic operator resources, IVDR challenges, UDI and labelling compliance, postmarket surveillance postmarket clinical follow-up and the consequences of a no Brexit deal and fewer notified bodies.

Sufficient Clinical Evidence

Presenting sufficient clinical evidence is an important aspect of the EU’s MDR. European medical device expert, Leo Hovestadt, evaluates what is considered “sufficient clinical evidence” and covers its important place in EU MDR in “What is Sufficient Clinical Evidence According to the MDR?” The author defines sufficient clinical evidence and discusses the kinds of clinical evidence required and what evidence can be considered state-of-the-art. Equivalent devices and benchmark/similar devices are discussed as well as performance studies.

Economic Operators

MDR and IVDR introduce a complete economic operator regime for medical devices. While the old directives replaced by these regulations regulated only the manufacturer and the authorized representative, the MDR and IVDR regulate the importer and the distributor, covering the supply chain up to the end-user. Legal experts, Agnes Szoboszlai and Erik Vollebregt, discuss how the Economic Operators (EOs) under MDR and IVDR can organize themselves and cooperate in such a way that each of their obligations can be fulfilled without unnecessary repetition of action while providing objective evidence of completion and ensuring compliance. In “Implementation of Shared MDR Economic Operator Resources,” the authors suggest how cooperation can be realized, both in the case of internal and external economic operators by using shared resources and tools. They discuss the obligations of manufacturers, authorized representatives, importers and distributors and describe the shared tools which can be either realized by shared quality management systems or agreements…