There is a lot of buzz in the industry right now around the EU MDR. An equally critical and potentially more burdensome transition is that to the EU IVDR for manufacturers of in vitro diagnostic products. I’ve noted a discrepancy in the resources for the EU IVDR transition and my clients feel the same way! In many ways, the EU IVDR transition marks a more significant change for these organizations than the changes for medical device organizations brought on by EU MDR. Here are three ways the transition may be more challenging for you than your colleagues who are adapting to the MDR:
1) Classification
The EU MDR brings about some changes to classification of medical devices; however, more systemic changes are brought by the IVDR for IVDs. The classification of IVDs is now assessed using 7 rules to classify each IVD into one of four classifications. IVDs will be classified into classes A – D with increasing level of risk. IVDs that do not fit into the existing classification structure will be Class B and will require certification by a notified body along with other Class B, C, and D devices. With this new classification structure and related changes, IVD manufacturers will require significantly more involvement from Notified Bodies for CE-marking.
2) Annex XIII
While clinical evaluation requirements for both IVDs and medical devices have definitely increased, medical device manufacturers were somewhat eased into the new requirements by the transition to revision 4 of MEDDEV 2.7/1 and the expectation of many notified bodies that clinical evaluation reports explicitly comply with the guidance. In some cases, Notified Bodies even required compliance to elements of the MEDDEV while it was still in draft form. The transition for in vitro diagnostics manufacturers to the EU IVDR is more abrupt. Look no further than the drastic increase in requirements from Annex XIII of Directive 98/79/EC to Annex XIII of EU Regulation 2017/746. New requirements for performance evaluation, performance studies, and post-market performance follow-up (PMPF) add substantially to the burden of technical documentation for IVD manufacturers. For the PMPF, suitable data and a justification for not performing PMPF must be documented as grandfathering based on existing CE-mark is not possible.
3) Post-Market Surveillance
Like the statements regarding Annex XIII above, IVD manufacturers have another sudden transition requiring the overhaul of a considerable element of the Quality Management System. While post-market surveillance requirements have been steadily growing for medical device manufacturers, the new requirements in the EU IVDR are a big step up for IVD manufacturers. The new system requirements are indeed a tall order; however, integrating post-market surveillance with other areas of the Quality Management System may be even more challenging. With IVDR, there are new PMS requirements that link to various other elements of the QMS which also require revamp for compliance. This task requires strategic revision and implementation.
Brosseau Consulting can assist your organization with the EU IVDR transition with tried and true methods that have been in use under the MDD and now the MDR. Please contact Bryan here for more information and a complimentary initial consultation on the EU IVDR or EU MDR transitions.