New guidance by the Medical Device Coordination Group spells out many of the routine aspects of compliance with the In Vitro Diagnostic Regulation, but test developers should remain aware of the tripwires in connection with modifications to both the test and the test’s performance studies.
The EU’s Medical Device Coordination Group issued a guidance on the types of products that qualify as in vitro diagnostics (IVDs), including some important distinctions even in instances in which a given analyte is the subject of two tests.
The European Medicines Agency seems focused on pharmaceuticals to the near exclusion of medical technology, but the agency recently reported the launch of a pilot program for orphan medical devices.
The European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) each allow a hospital to develop a device or an in vitro diagnostic for use solely in that hospital, but there is no regulatory free pass despite the lack of commercial intent. While the latest guidance on these in-house tests acknowledges that the hospital must determine the degree to which it must comply with the relevant regulation, any hospital that makes and uses an in-house diagnostic or device must develop a risk management mechanism for that device or diagnostic, not an easy lift for entities that may be glancingly familiar at best with conventional regulatory schemes.
The European Union’s efforts to update its regulatory framework for medical devices was heralded as a long-overdue response to the Poly Implant Prothèse (PIP) breast implant scandal, but the COVID-19 pandemic added significant drag to the implementation timelines. Those timelines have proven impracticable for other reasons as well and the problem will bleed into the new year and perhaps beyond to the detriment of patients and manufacturers.
EU health ministers have warned that developers of medical devices face trouble ahead in meeting deadlines for implementing the two new key regulations for medical devices (MDR) and in vitro diagnostics (IVDR). These were planned to enter into force in May 2021 and May 2022 respectively. EU executives and stakeholders have now all accepted that delays in complying with the regulations could result in issues achieving certification for medical devices, threatening shortages in the market.
The EU’s Medical Device Coordination Group (MDCG) has advised the device industry that many manufacturers seem ill prepared for the transition to the Medical Device Regulation (MDR), which will be fully in force for all devices as of May 2024. MDCG said that that any leniency shown after that date will be granted only for devices that address an urgent public health need, potentially leaving many existing authorizations out in the cold.
The mutual recognition agreement between Switzerland and the EU for medical devices lapsed in 2021, a development that was expected to add a significant amount of drag on Swiss device exports to EU nations.
The European Union’s (EU) Medical Device Coordination Group (MDCG) posted a guidance addressing verification of manufactured, high-risk in vitro diagnostics (IVDs), which indicates that manufacturers should submit samples to a reference lab for batch testing. However, the requirement for batch testing may not apply if no European reference lab has been designated for a test type, suggesting that some high-risk tests may go to market without adequate testing.
The guidances for in vitro diagnostics (IVDs) developed by the European Union’s Medical Device Coordination Group (MDCG) are only a reflection of the In Vitro Diagnostic Regulation (IVDR), but they do provide test developers with some important details.
