EU’s New Guidance on Harmonized Standards

by Nikita Angane | May 10, 2021 | EU, EU MDR, Harmonization, Quality, Standardization, Standards

The EU Commission released a new guidance document clarifying the purpose of harmonized standards under the EU Medical Device Directives and the new Medical Device Regulations. The new guidance mentions that though meeting the requirements of harmonized standards is voluntary in the process of obtaining a CE mark, demonstrating compliance to harmonized standards provides the manufacturer benefit of “presumption of conformity” with the relevant legal requirements.¹

Conforming to the harmonized standards though voluntary as stated before, allows for easy, quick, streamlined, and less burdensome conformity assessment processes, post-market surveillance planning, etc. Since the use of these standards is voluntary, neither the regulators nor the notified body has the authority to impose the use of these standards.¹

The guidance document further clarifies the usage of the concept “state of the art”, references to which can be found throughout the directives and the regulations. The guidance states that even though the directives and the regulations mention requirements “to take into account the generally acknowledged state of the art” requirements to meet the health, safety and performance requirements, the statement “taking into account” is different than “compliance” and that is what makes “state of the art” not legally binding, but still useful to consider when designing and manufacturing the products. ¹

This guidance document definitely clears some of the questions that the industry has been seeking answers for, as outlined in our previous blog APPLICATION OF HARMONIZED VS LATEST VERSION OF STANDARDS and gives the manufacturers a sign of relief when it comes to complying with the harmonized standards.

Whatever challenges you have with your product development or in your EU MDR transition, rest assured that EMMA International is here to assist you with all your compliance needs, call us today at 248-987-4497 or email us at info@emmainternational.com to learn more.

¹MDCG (April 2021) Guidance on standardization for medical devices retrieved on 05/02/2021 from https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2021_5_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.