The International Medical Device Regulators Forum (IMDRF) has recently issued drafts of two separate guidance documents that may be of interest to medical device manufacturers.
The first draft guidance of essential safety and performance principles for medical devices is actually a revision of an IMDRF guidance originally issued in 2012. The proposed draft revision is part of the IMDRF efforts to further harmonize the documentation and procedures used to assess whether a given medical device conforms with the regulatory requirements that apply in each jurisdiction, and to further encourage and support efforts to achieve greater global convergence of regulatory systems applicable to medical devices.
The second draft guidance on optimizing standards for regulatory use is intended to provide recommendations to both regulatory authorities and standards development organizations on practices for more effectively integrating standards and standards requirements into the regulatory framework.
The IMDRF is the voluntary group of medical device regulators behind the Medical Device Single Audit Program (MSDAP), a mutual recognition program intended to ease the compliance burden on device manufacturers by streamlining and harmonizing the process of conducting pre- and post-market audits required by most regulatory authorities. Under MDSAP, audits conducted by any IMDRF-authorized Auditing Organization are recognized by regulators in IMDRF-participant jurisdictions as meeting their quality management system requirements.
The text of the IMDRF’s draft revision on its guidance on essential safety and performance principles for medical devices is available at http://www.imdrf.org/docs/imdrf/final/consultations/imdrf-cons-epsp-n47.pdf. The draft guidance on optimizing standards for regulatory use is available at http://www.imdrf.org/consultations/cons-swg-optimising-standards-n51-180524.asp.
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