EU’s Clarification on Medical Device Remote Audits

by Nikita Angane | Dec 11, 2020 | Audits, FDA, Medical Devices, Quality, Regulatory, Remote

The European Commission published a new guidance document that clarifies certain requirements originally outlined in MDCG 2020-4: Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions.¹

The new guidance clarifies the scope of MDCG 2020-4 and further states that the guidelines are applicable to:¹

All devices requiring the involvement of a notified body, thus not limited to COVID-19 essential medical equipment.
Initial certification audits under the directives, however, the notified body must perform a case-by-case assessment
Audits to extend the certification under the directives, which also requires the notified body to do a case-by-case assessment
Audits of existing and new critical subcontractors/suppliers under the Directives

Unannounced audits are not included in the scope of this guidance, however, a risk-based approach must be applied in recognizing the need to postpone such audits. ¹

A list of devices clinically necessary for COVID-19 has been published on the EU Commission’s website and can be found here: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_list-covid19-essential-md.pdf however, the guidance document states that the MDCG 2020-4 does not just apply to products that are considered clinically necessary and that all devices requiring the involvement of a notified body are included in the scope.¹

Additionally, the guidance document clarifies the use of ‘Most advanced’ information and communication technologies (ICT), stating that the MDCG does not require a particular ICT to be used in audits, however, the ICT must be effective in ensuring the necessary levels of security, integrity, confidentiality, and data protection.¹

Furthermore, the technology should allow auditors to gather evidence and record it appropriately whenever necessary and retain copies of documentation submitted by the manufacturer for later review, as deemed appropriate to preserve the audit trail.¹

COVID-19 has certainly brought some unique challenges to all industries and everybody is trying to do their bit. EMMA International is here to help with all your compliance needs in such difficult times! Give us a call today at +1 248-987-4497 or email us at info@emmainternational.com to know more.

¹EU Commission (Dec 2020) MDCG 2020-17 Questions and Answers related to MDCG 2020-4 retrieved on 12/10/2020 from https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_2020-17-guidance-mdcg-qa_en.pdf

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.