Availability of Notified Bodies for Conformity Assessments

by | Jul 15, 2020 | FDA, Medical Devices, notified body, Requirements

The EU Commission committed to provide information on the availability and the capacity of the notified bodies to conduct conformity assessments in the Joint European Roadmap towards lifting COVID-19 containment measures released on April 15, 2020.1 The EU commission conducted a survey of the notified bodies to obtain that information for the market operators to help them plan their market access.2

Thirty seven out of the fifty five notified bodies participated in the survey. Out of which, 16% of the notified bodies are not taking new applications, and 8% are not taking in any applications related to notification of change. If a manufacturer decides to add a new product to its portfolio that is related to COVID-19, it may take up to one to three months for its assessment.1

Given the fact that several manufacturers who were not an active manufacturer in the medical device industry have jumped in to ramp up the supply of COVID-19 essential products, they need to be assessed for their conformity to the standards. In such cases, the notified bodies have to conduct an assessment of their entire quality system for the first time and given the limited capability to carry out on-site audits, 61% of the notified bodies reported that an assessment procedure for a class I sterile product would last between 1-3 months, and 47% reported that for a class IIa, it would be 3-6 months.1

It gets even more difficult for companies trying to seek their EU MDR certificate. The number of notified bodies designated under the MDR are limited and around 10% of those designated notified bodies have stopped accepting new applications.1

The EU commission released a list of COVID-19 essential medical devices to help notified bodies prioritize the assessments to help with the shortages in the supply. The list can be accessed here: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_list-covid19-essential-md.pdf.

Regulatory authorities all around the world are trying to mitigate the supply shortages while safeguarding public health. If you have a medical device that can help with Covid-19, call us today to know how it can be brought to the market. Call us at 248-987-4497 or email us at info@emmainternational.com.

1EU Commission (April 2020) Joint European Roadmap towards lifting COVID-19 containment measures retrieved on 07/08/2020 from https://ec.europa.eu/info/sites/info/files/communication_-_a_european_roadmap_to_lifting_coronavirus_containment_measures_0.pdf

2EU Commission (June 2020) Availability and capacity of notified bodies to carry out conformity assessments for COVID-19 related medical devices and in vitro diagnostic medical devices retrieved on 07/08/2020 from https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_survey-conformity-assess-covid-19.pdf


Nikita Angane

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.

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