As a company that specializes in medical device testing, we often encounter some common misconceptions and myths about the regulatory requirements and processes for obtaining medical device certificates from the European Union’s Medical Device Regulation (MDR) and the U.S. Food and Drug Administration (FDA). In this series of posts, we will debunk some of these myths and provide some facts and tips to help you navigate the complex and dynamic regulatory landscape.
MYTH #1.
MDR and FDA have the same requirements and procedures for medical device testing.
FACT:
MDR and FDA have different regulatory frameworks, definitions, classifications, and conformity assessment procedures for medical devices. For example, MDR defines a medical device a little differently than the FDA. Furthermore, MDR classifies medical devices into four risk-based classes: I, IIa, IIb, and III, while FDA classifies medical devices into three risk-based classes: I, II, and III. MDR requires manufacturers to undergo a conformity assessment procedure involving a notified body (an organization designated by an EU country to assess the conformity of certain products) for all classes except class I devices, while the FDA requires manufacturers to submit a premarket notification (510(k)) or a premarket approval (PMA) application for most class II and III devices, respectively, and to register their establishment and list their devices with the FDA.
TIP:
To ensure compliance with both MDR and FDA, manufacturers should consult the relevant guidance documents, standards, and regulations, and seek expert advice from qualified testing labs, notified bodies, and regulatory consultants.