MDCG Offers Guidance to Help Class I Device Manufacturers
As the corrigendum for some Class I devices was adopted on Tuesday, the European Medical Device Coordination Group (MDCG) late Tuesday released new guidance to help manufacturers of Class I devices comply with the provisions of the incoming Medical Devices Regulation (MDR).The 22-page guidance covers the necessary steps for placing Class I devices on the market, which include meeting general safety and performance requirements, preparing technical documentation, requesting notified body involvement in certain circumstances, preparing instructions for use and labeling and registering the device in a database known as Eudamed.
As far as meeting the general safety and performance requirements, the guidance explains that manufacturers will establish and implement a risk management system to identify and analyze the hazards associated with each device, as well as the associated risks, while eliminating or controlling residual risks.
The guidance also explains how all devices, regardless of class, require a clinical evaluation as part of MDR.
“For devices which are currently certified with respect to the Directive 93/42/EC, and for which the available clinical data are not sufficient to demonstrate compliance with MDR, additional clinical data may be obtained by post-market clinical follow-up studies of the device. Sometimes, even data from the general post-market follow-up might suffice to close the gap,” the guidance says.
But in “duly justified and substantiated cases,” some Class I device manufacturers “may exceptionally demonstrate that the conformity with general safety and performance requirements based on clinical data is not deemed appropriate. Such a justification by the manufacturer must be based upon an evaluation of evidence in accordance with Article 61(10),” the MDCG says.
But some Class I devices would begin to require a notified body (NB) under MDR (although the latest MDR corrigendum pushes back the deadline for their compliance by four years).
“In the case of devices placed on the market in sterile condition, having a measuring function or being reusable surgical instruments, the manufacturer will apply the procedures set out in Chapters I and III of Annex IX, or in Part A of Annex XI of MDR. This requires the involvement of a NB. In all other cases the intervention of a NB is not required for Class I devices,” the guidance says.
In the postmarket setting, the guidance notes that Class I device firms should “actively and regularly” collect user experiences from marketed devices, reviewing these and “ensuring timely implementation of any necessary corrective action, taking account of the nature and risks in relation to the product. In addition, there should be an evaluation of whether the intended benefits are achieved and whether the benefit-risk profile stays positive.”
As far as reporting serious incidents, the guidance says that serious public health threats need to be reported no later than two days after manufacturers become aware of a threat.
In the event of death or an unanticipated deterioration in a person’s state of health, the guidance says, a report will be submitted no later than 10 days after becoming aware of the serious incident. And in all other cases, reports need to be submitted no later than 15 days after becoming aware of the serious incident.
“Upon request, the manufacturer will provide all the information and documentation necessary to demonstrate conformity of the device to competent authorities and cooperate with them on any corrective action. If the manufacturer does not cooperate or does not provide the requested information or documentation, the competent authority (CA) can adopt restrictive measures,” the guidance adds.
MDCG 2019-15 GUIDANCE NOTES FOR MANUFACTURERS OF CLASS I MEDICAL DEVICES