The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has announced public consultations related to the document issued recently by the IMDRF. The International Medical Device Regulators Forum (IMDRF), a voluntary association comprised of the representatives of the national regulating authorities collaborating for the purpose of further improvement of the regulatory framework for medical devices, has developed a consultation paper dedicated to the assessment and decision process for the recognition of a conformity assessment body (CAB) conducting medical device regulatory reviews. 

Regulatory Background

By the virtue of the present document, the IMDRF intends to suggest the approach allowing to improve the efficiency and effectiveness of the review process medical devices are subject to before being allowed for marketing and use in the respective countries. 

The IMDRF also refers to additional documents covering other aspects related to the requirements a conformity assessment body should meet, namely:

  • IMDRF GRRP WG/N40 – Competence, Training, and Conduct Requirements for Regulatory Reviewers, and
  • IMDRF GRRP WG/N59 – Requirements for Medical Device Conformity Assessment Bodies for Regulatory Authority Recognition. 

The aforementioned documents outline the main regulatory requirements the conformity assessment bodies should comply with in order to be allowed to conduct reviews of both general and in vitro diagnostic medical devices prior to marketing. 

The IMDRF also mentions two other documents addressing the matters related to the way the regulatory authorities should evaluate compliance of the conformity assessment bodies with the applicable requirements mentioned hereabove. These documents include:

  • IMDRF GRRP WG/N61 – Regulatory Authority Assessment Method for Recognition and Surveillance of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews, and 
  • IMDRF GRRP WG/N63 – Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews. 

The present document named IMDRF GRRP WG/N66 – Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Devices Regulatory Reviews are intended to provide additional clarifications with regard to the approach to be applied by the regulating authority when assessing compliance of a conformity assessment body with the regulatory requirements applicable thereto. The document also outlines the particular way the aforementioned process should be documented.

For the clarity of wordings used, the IMDRF states that the term “review” should be used in the context of medical device reviews conducted by a conformity assessment body within the scope of its designation in order to determine whether the medical device in question complies with the respective regulatory requirements. At the same time, the term “assessment” for the purpose of the document should be used only when referring to the assessment performed by the regulating authority with regard to the conformity assessment body as described hereabove. Thus, all activities carried out by the regulating authority, including the recognition and surveillance, are covered by the scope of the term “assessment.”

According to the IMDRF, the requirements described in the present document should be used by the national regulating authorities when developing their approach to the aspects addressed herein. In particular, they cover the processes related to recognition (under the EU framework also refers to as the designation) of conformity assessment bodies and ongoing monitoring of their activity. By the virtue of the present document, the IMDRF intends to provide the recommendations to be considered by the regulating authorities in order to establish a balance between ensuring sufficient control and oversight over the activities carried out by conformity assessment bodies while avoiding unneeded regulatory burden.

Regulatory Review: Key Points 

As it is stated by the IMDRF, the present document describes:

  • The process and lifecycle for recognizing, maintaining, or ceasing recognition of a conformity assessment body;
  • the process of managing, grading, and closure of assessment nonconformities issued to a conformity assessment body; and
  • The outcomes of an initial, surveillance, or re-recognition assessment process of a conformity assessment body. 

For the purpose of the document, the IMDRF refers to other guidance documents issued previously by the association and addressing various aspects related to the competence of personnel conducting the assessment, essential principles of safety and performance of medical devices, applicable standards, regulatory requirements in terms of labeling, as well as the principles of conformity assessment of various medical devices including the in vitro diagnostic medical devices. 

The present IMDRF document also provides the definitions of the most important terms used in the context of the assessment of conformity assessment bodies conducted by the regulating authorities. The terms explained in the document include, inter alia, the following ones: 

  • Assessor – an in-house specialist of the regulating authority entitled to carry out a CAB assessment; 
  • Assessment – a systematic, independent, and documented process for obtaining assessment evidence and evaluating it objectively to determine the extent to which assessment criteria are fulfilled. 
  • Quality Management System – a set of measures and activities implemented by the entity in order to identify the main objectives and establish the processes to be performed to achieve the expected outcomes. The QMS actually deals with the optimization of utilization of the resources the entity has. 
  • Regulatory Review – an activity to be carried out in order to evaluate whether the medical device in question complies with the applicable regulatory requirements. 

Regulatory Requirements in Detail 

According to the applicable regulatory requirements, the overall review process should be based on a 3- or 4-year cycle comprised of several annual assessments and periodical re-recognition assessments to be conducted once in 3 or 4 years respectively. Thus, the assessment cycle includes:

  • Initial Assessment, 
  • Annual Surveillance Assessment,
  • Re-Recognition Assessment. 

The IMDRF also mentions that in certain cases the Special Assessments could take place. Depending on the particular circumstances, they could be carried out either in the form of on-site inspection or in remote format with the use of teleconferencing technologies. 

The IMDRF additionally emphasizes that a conformity assessment body may apply for reduction or extension of its recognition scope which outlines the types of medical devices it is entitled to review. Under the general rule, this process should be initiated before the next re-recognition audit in order to include all new aspects in its scope.  

According to the document, the applicable regulatory requirements should cover such aspects as: 

  • Regulatory review process or technique;
  • Regulatory review time frames;
  • Limits on the type of regulatory reviews able to be completed by CABs, versus regulatory reviews that need to be completed by the regulatory authority;
  • The need for a quality management system audit of certain medical device manufacturing facilities as part of the marketing certification process;
  • Regulatory review report requirements; or
  • Certification document requirements. 

Summarizing the information provided here above, the present IMDRF document addresses the most important aspects related to the assessment to be carried out by the regulatory authorities in order to ensure the designated (recognized) conformity assessment bodies conduct the reviews of medical devices strictly in accordance with the applicable regulatory requirements. The document also describes the way the regulatory authorities should perform such an assessment and which aspects should be considered in this regard. 

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