Clinical Literature Reviews for Regulatory Submissions: Not Just for the EU

By Erica Kramer, Ph.D.

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Systematic clinical literature reviews are essential for achieving and maintaining regulatory compliance, most notably in the EU. However, systematic clinical literature reviews are also essential components of the regulatory process in other markets, including China and Canada. Literature review requirements differ for EU MDR, Health Canada, and China NMPA submissions.

For details regarding clinical literature reviews for the EU, see Nerac’s prior articles EU MDR CER Literature Review Process: Expectations and Best Practices, Best Practices for the State of the Art Evaluation, and Leveraging Clinical Literature Reviews Across Multiple Regulatory Deliverables for the EU.

Per the Chinese Regulations for the Supervision and Administration of Medical Devices (State Council Order No. 739) issued in 2021, Article 25 [1]:

The clinical evaluation of medical devices can be carried out according to the product characteristics, clinical risks, existing clinical data, etc., through clinical trials, or through analysis and evaluation of the clinical literature and clinical data of the same variety of medical devices to prove the medical treatment/the equipment is safe and effective.

Though there are some differences in requirements between clinical literature reviews for the EU MDR and clinical literature reviews for Order 739, for both markets a comprehensive literature review, using a systematic and transparent approach, is essential to ensure that all relevant clinical data are included in the clinical evaluation report, and included data must be adequately appraised for relevance and quality.

Per the Health Canada Medical Devices Regulations SOR/98-282, last amended on March 2, 2022, provision 61.4 [2]:

61.4 (1) The holder of a medical device licence shall prepare

(a) in the case of a Class II medical device, on a biennial basis, a summary report of the information that pertains to the matters referred to in subsection (2) and that the licensee received or became aware of during the previous 24 months; and

(b) in the case of a Class III or IV medical device, on an annual basis, a summary report of the information that pertains to the matters referred to in subsection (2) and that the licensee received or became aware of during the previous 12 months.

The information covered in subsection (2) includes adverse effects, problems, incidents, and serious risks relevant to the safety of the medical device. Though the use of clinical literature for a Summary Report is not specified in the regulations, guidance suggests that, if available, “information on safety or effectiveness (including published reports)”: should be included in the analysis. It is also key to note that the guidance states that [3]:

Different formats are acceptable for a summary report, including those from other jurisdictions, as long as the report includes the required information outlined in sections 61.4(1) to 61.4(5) of the Regulations.

For example, the Periodic Safety Update Report format as required in the European Union may be an acceptable approach to fulfilling the summary report requirement in Canada.

Additionally, in the case of Class IV medical devices, according to provision 32(4) of the Canada Medical Devices Regulations, applications should contain “detailed information on all studies on which the manufacturer relies to ensure that the device meets the applicable requirements… [including] literature studies”.

Requirements by the regulatory authorities are increasingly demanding comprehensive, transparent, and repeatable systematic literature reviews, thus straining many medical device manufacturers’ internal cross-functional teams. Though the specific requirements vary by market, smart planning can enable leveraging systematic searches of the clinical literature across multiple regulatory deliverables, saving time and money. This leverage effort is likely to be more complex than a direct copy-paste between documents; therefore, a thorough understanding of the requirements for each market, as well as a high-quality and transparent search, review, and recordation process is essential.

How can Nerac help?

Nerac has the literature review expertise required to design and perform thorough and efficient literature reviews in compliance with EU MDR, NMPA Order 739, and Health Canada Medical Devices Regulations SOR/98-282 requirements. Contact Nerac today to discuss strategies for leveraging literature review efforts that will best fit your needs.

Footnotes

[1] The original regulation in Chinese, found at www.nmpa.gov.cn, shall prevail.

[2] https://laws-lois.justice.gc.ca/eng/regulations/sor-98-282/

[3] https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/medical-device-reports-analyses-guidance/summary.html

About the Analyst

Erica Kramer, Ph.D., Nerac Analyst

Erica works with medical device clients to conduct research of the clinical literature, prepare Clinical Evaluation Reports, and conduct focused research to address clients’ critical questions relating to the medical device industry across many device and therapeutic areas.

Academic Credentials

  • Ph.D. Materials Science and Engineering, University of Connecticut
  • M.S. Biomedical Engineering, University of Connecticut

Professional Memberships:

  • Regulatory Affairs Professionals Society
  • Society for Biomaterials
  • Materials Research Society

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