Convergence: Manufacturers failing to grasp ‘step change’ in requirements under MDR

Some manufacturers are failing to grasp the step change in clinical and risk management requirements imposed by the Medical Devices Regulation (MDR), Kevin Butcher told attendees at RAPS Convergence 2021.
 
Butcher, principal regulatory consultant at medical device contract research organization NAMSA, used his presentation at the event to discuss his practical experience of the challenges the European Union legislation is creating for the industry. The session focused on the current transition period in which manufacturers can place devices on the market with certificates issued under the old directive but must comply with aspects of MDR.
 
There is a failure to grasp the extent of the changes required under MDR, notably the “total rewriting of existing procedures” that is required in clinical and risk management areas, Butcher said. In some cases, there have been fundamental misunderstandings about what is required during the transition period that runs from 2021 to 2024.
 
“It's been assumed that because they are still using the MDD certification, that their QMS is not required to be updated until they move to the MDR. This is not true,” Butcher said. Manufacturers need to update their quality management systems (QMS) in line with MDR even if their products are still certified under the outgoing directive.
 
When companies do update their QMS, some are failing to use guidance provided by the Medical Device Coordination Group (MDCG) to inform their changes. As another speaker, BSI regulatory director Suzanne Halliday, explained later in the session, MDCG guidance is not legally binding. Yet, as notified bodies will use MDCG guidance when reviewing a manufacturer’s documentation, there is still value in using the materials to shape updates to QMS.
 
Risk management is one area that needs updating in response to MDR. Butcher recommends basing risk management on the latest ISO standards and MDR, with the latter taking precedence in areas in which they diverge.
 
“A lot this is fairly obvious, but risk management is a continuous iterative process that must be regularly and systematically updated. There must be a plan for each device, and not a generic plan,” Butcher said.
 
Halliday followed on from Butcher. While noting that MDCG guidance is not legally binding, the BSI regulatory director said it is “incredibly valuable” to read the coordination group’s publication about unique device identifiers (UDIs). “In BSI’s experience so far, we are finding manufacturers struggle with some of the concepts of basic UDI-DI, under both the MDR and the IVDR,” Halliday said.
 
Erica Conway, global head, in vitro diagnostic medical devices at BSI, shared a closer look at work to prepare for IVDR, which is running to a slightly different timeline than MDR. With most IVDs needing to meet the new regulatory requirements by May 2022, Conway said manufacturers are finding fulfilling the requirements of clinical evidence to be the biggest hurdle to IVDR certification.
 
Conway dug into IVDR to show what sources of evidence manufacturers can use to demonstrate the clinical performance of their products. “It is possible for a manufacturer to be supporting their clinical performance by other sources of data, and not necessarily needing a new clinical performance study, if the data presented does support those claims,” Conway said.
 
RAPS Convergence 2021