QMS and the IVDR: Roles and responsibilities

Person responsible for regulatory compliance (PRRC)

One of the new key areas of responsibilities that needs to be defined is the person or persons responsible for regulatory compliance per Article 15. If more than one person maintains this role (to help the manufacturer meet the accessibility requirement), the divisions of responsibility will need to be documented in writing, such as in job descriptions, objectives, performance-related criteria and so on. As the qualification requirement for this role can be fulfilled through either education (diploma/certification) or through experience, it is important to ensure that objective evidence is maintained within the records associated to the person(s) named. The experience requirements are specific to in vitro medical devices, and experience in other types of medical devices/QMS is likely to be considered inadequate.

Beyond the role description and list of respective responsibilities, the manufacturer should be ready to demonstrate through records that the person responsible for regulatory compliance has indeed been acting in the expected capacity. This includes covering the conformity of devices being manufactured and released, the technical documentation and EU declaration of conformity, post-market surveillance obligations, reporting obligations and the specific classes of performance studies involving interventional devices or risk to patients. It should not be interpreted or expected that the PRRC is reviewing or approving each of these documents his or herself, as this responsibility can be delegated through procedure. Objective evidence of PRRC involvement can include, but is not limited to, approving procedures that cover these areas, approving reports dealing with these items or participation in management reviews where these topics are covered. Finally, specific attention is drawn to 15(5) which states that the PRRC ‘shall suffer no disadvantage within the manufacturers organization in relation to the proper fulfilment of his or her duties…’. It could be helpful for this to be reflected in the relevant job descriptions or contracts.

Economic operators

In addition to the person responsible for regulatory compliance, the IVDR has defined a number of responsibilities for various economic operators (importers, distributors and authorized representatives). The manufacturer needs to ensure that these various responsibilities, and their oversight of them, are documented as part of the QMS. The authorized representative must accept, in writing, the designation of responsibility, and other economic operators will find that they have responsibilities to verify various aspects of product compliance. It is advisable to review the roles and responsibilities among various economic operators, ensuring that each party is prepared to fulfil the IVDR, as well as ensuring access to the necessary records. Manufacturers should review contracts with their various economic operators and verify that these agreements are clearly documented in writing, including all new responsibilities.

Management responsibilities

The regulation also clearly requires that the management of resources necessary to implement and to carry out the procedures and policies be defined within the QMS. To comply with these expectations, the QMS must include adequate provisions to review the allocation of resources to key processes as well as management reviews which are aimed at identifying if a process is under-resourced. For example, corrective actions which are systematically late could be indicative of an inadequate provision of resources.

Management of resources also includes the selection and control of suppliers and subcontractors, with emphasis on critical suppliers in accordance with risk. Any processes which are assured through suppliers and subcontractors need to have adequate controls defined to demonstrate that these are under control. This should include selection and/or qualification criteria, as well as process for monitoring performance/output. For critical or high-risk suppliers, a regular audit program is also advisable. As with other clauses, the key is to scale the actions commensurate with the risk.

This is an excerpt from the white paper Developing and maintaining a quality management system for IVDs. To download our other medical device white papers, please visit the Insight page on the Compliance Navigator website.