Medical Device and IVD Classification Support

Why Device Classification Matters

Device classification is one of the most critical early regulatory decisions a manufacturer makes. Classification determines the regulatory framework that applies to a product, including evidence requirements, conformity assessment routes, post-market obligations, and regulatory timelines. Errors or assumptions at this stage can result in significant downstream compliance issues.

Under the EU MDR and IVDR, classification rules are more granular than under the previous directives and often require careful interpretation. Small differences in intended use, mode of action, or user population can shift a device into a higher risk class, triggering additional regulatory requirements. For IVDs in particular, the IVDR classification system has introduced substantial changes that many manufacturers continue to underestimate.

In the United States, classification influences whether a device is eligible for a 510(k), requires a De Novo request, or is subject to PMA. While FDA product codes and predicates provide guidance, classification is not always straightforward, particularly for novel technologies or devices that combine multiple functions.

Classification decisions also affect global regulatory planning. Manufacturers pursuing multiple markets must understand how classification differs across jurisdictions and how those differences influence evidence generation and submission sequencing. Without coordinated planning, manufacturers may generate unnecessary data or face avoidable delays.

Clear and defensible classification rationales provide a foundation for regulatory strategy, support efficient engagement with regulators, and reduce the risk of reclassification during review.