By Brian Moan, director of solutions delivery Europe; and Norm Rabin, director of solutions delivery at Maetrics
Improving patient safety and increasing transparency are two of the guiding principles of the new In Vitro Diagnostic Medical Device Regulation (IVDR), which must be implemented by all IVD manufacturers by 26 May 2022.
Technological progress and innovation in the sector has brought such a level of complexity to devices that previous legislation was simply not sufficient to fully protect patients
The fact is that technological progress and innovation in the sector has brought such a level of complexity to devices that previous legislation was simply not sufficient to fully protect patients.
Manufacturers must make substantial changes to guarantee their quality and control procedures are more robust and their implementation strategies are IVDR compliant.
Under the terms of the new regulation, the number of definitions of an IVD has increased to 74.
And, as the new IVDR stipulates that all products placed on the EU market are CE marked, Notified Body scrutiny for CE marking will now be needed for previously-unregulated devices.
The introduction of a new risk-based classification system divides IVDs into four classes, with A being the lowest risk and D the highest. Classification must now be determined by reviewing all rules, and the one deemed to have the highest risk applies.
As the new IVDR stipulates that all products placed on the EU market are CE marked, Notified Body scrutiny for CE marking will now be needed for previously-unregulated devices
As part of their ongoing assessment of potential safety risks, manufacturers will be compelled to collect clinical data and carry out post-market follow-up.
The introduction of a new version of the European Data Bank on Medical Devices (EUDAMED) will require manufacturers to record safety issues, corrective action taken, as well as produce regular summary reports.
Manufacturers should closely follow the development of the new EUDAMED system, which puts transparent and user-friendly access to IVD information at its core.
Manufacturers will need to upload all IVD products onto the system. Each IVD must be assigned a Unique Device Identification (UDI) from a UDI supplier to ensure traceability, and this information also transferred to EUDAMED. Products cannot be placed on the market until this is done.
Additional changes brought in by the new IVDR include the stipulation that companies appoint a Person Responsible for Regulatory Compliance (PRRC) who will oversee the transition at all points of the supply chain.
Requirements for product labelling are more prescriptive than before, too. For example, devices that contain dangerous substances must adhere to relevant hazard pictograms and labelling requirements.
Manufacturers must also be able to provide sufficient financial coverage for their potential liability and ensure that all technical documentation meets new, detailed specifications.
Faced with these challenging new regulatory demands, manufacturers will undoubtedly turn to Notified Bodies to guide them through this tricky transition period and ensure their products are IVDR-compliant in time. Unfortunately, Notified Bodies are not in a strong position to offer the services required of them. NBs themselves currently need to seek designation under the new IVDR.
It is vital that manufacturers understand that NBs might not be able to offer the hands-on support expected of them as they deal with their own need to meet IVDR criteria
Add to this that NBs across Europe are already experiencing significant workload pressure and that there has been a significant decrease in the number of NBs accredited to deal with in vitro diagnostic medical devices; and it is safe to say that demand on their services in the next five years will exceed capacity.
To increase the pressure further, NBs are also required to carry out unannounced inspections every five years.
Early preparation and action will be critical to ensure a smooth transition to full and timely IVDR compliance.
Seeking expert advice and outsourcing the compliance process is advisable to guarantee regulatory success, competitive advantage and continued access to the EU market
It is vital that manufacturers understand that NBs might not be able to offer the hands-on support expected of them as they deal with their own need to meet IVDR criteria.
Seeking expert advice and outsourcing the compliance process is advisable to guarantee regulatory success, competitive advantage and continued access to the EU market.