IVD Quality Management System Implementation Deadline
European lawmakers have started the countdown to the implementation of new medical device and in-vitro diagnostic (IVD) regulations. Manufacturers of all classes of device now have three to five years to implement quality management and post-market surveillance systems.
The documents came into the force late last month, triggering the start of a staggered introduction of the requirements. Manufacturers of medical devices have three years to comply. IVD businesses have five years. In both cases, some of the requirements come into force before the final deadline.
Both texts will affect quality assurance and quality control professionals. The regulations require device and IVD manufacturers to have systems for managing quality and tracking post-market safety. Lawmakers sought to cut the risk this will unnecessarily burden manufacturers of Class I devices by stating the systems “should be proportionate to the risk class and the type of the device in question.”
The laws also require companies to employ at least one person who is responsible for regulatory compliance. If this person has a university-level qualification in a relevant discipline, such as law or medicine, they need one or more years of professional experience in regulatory affairs or quality management systems to be eligible to fill the role. People who lack such a qualification need at least four years of experience.
Lawmakers have again provided some flexibility to manage the burden imposed by the rule. The flexibility applies to micro and small enterprises. Such companies are allowed not to have a person responsible for compliance within their organization provided someone with this role is “permanently and continuously at their disposal.”
The responsibilities of this person include checking the conformity of devices, keeping technical documentation up to date and ensuring their employer complies with its post-market surveillance obligations.
Medical device manufacturers have until May 26, 2020 to comply with the requirements. The deadline for compliance by IVD companies is two years later in 2022.