The International Medical Device Regulators Forum (IMDRF) has a draft guidance document released for public consultation on the regulatory review of medical devices performed by Conformity Assessment Bodies (CABs).
This text forms the latest in a series of guidance documents the IMDRF is developing in order to establish a harmonised global regulatory approach to medical devices and In Vitro diagnostics (IVDs). This guidance highlights the proposed procedure for evaluating a CAB’s performance, along with the resultant outcomes and any potential impact this may have on manufacturers associated with a particular body.
The document defines CABs as “a body other than a Regulatory Authority engaged in determining whether the relevant requirements in technical regulations or standards are fulfilled” whilst the regulatory authority is defined as “A government body or other entity that exercises a legal right to control the use or sale of medical devices within its jurisdiction, and that may take enforcement action to ensure that medical products marketed within its jurisdiction comply with legal requirements.” These definitions are vital in highlighting the distinction between regulatory review activities conducted by a CAB and assessments of a CAB conducted by the relevant regulatory authority.
The key activities covered by this guidance are:
- The process and lifecycle for recognising, maintaining or ceasing recognition of a CAB
- The process of managing, grading and closure of assessment nonconformities issued to a CAB
- The outcomes of an initial, surveillance or re-recognition assessment process of a CAB.
The IMDRF has released the document for consultation to gain feedback from relevant stakeholders. The consultation ends on 19 April 2021.
To view the full guidance, click here.