This presentation compares the Essential Requirements of the Directives with the new General Safety and Performance Requirements (GSPRs) of the MDR.
In many areas, these changes are not significant. They remain focused on achieving device safety and performance through risk management, benefit-risk determination, safe design and manufacturing, microbial cleanliness, environmental properties, radiation protection, labelling and IFUs.
The MDR GSPRs do contain, however, more detailed requirements regarding devices that contain hazardous chemicals, medicines, and materials of biological origin. For certain devices, these new requirements may prove very significant. There are also more specifics regarding devices that are in the form of software, and devices intended for use by lay persons. The MDR GSPRs also create new labelling and IFU challenges.
Today, manufacturers demonstrate their devices’ conformity with the Essential Requirements primarily through a clinical evaluation combined with application of harmonised standards and other non-clinical methods. The MDR places more emphasis on clinical evaluation as the de facto source of evidence that a device complies with the GSPRs. This in turn raises questions about the future role of non-clinical solutions in demonstrating compliance.
Like the Directives, the MDR requires manufacturers to document their evidence of compliance with the GSPRs in the technical documentation. While Authorised Representatives are only required, strictly speaking, to ‘verify’ that the technical documentation has been drawn up, under the MDR they will share liability with manufacturers for defective devices. This raises the question of whether Authorised Representatives could soon assume new, informal roles in policing their manufacturers’ future compliance with the GSPRs… and whether they are sufficiently motivated and equipped to do so.
Please note that the requirements for IVDs are addressed in another session, and are therefore intentionally not covered in this presentation.