Kristina Zvonar Brkic If you are a manufacturer in the European Union, it can be difficult to try to align the different standards in the various countries. As it turns out, the EU has released a list of harmonized standards to help you decide what you need to do. EU harmonization, and the EU harmonized standards, try to make it easy to determine what you need to do.
What is EU harmonization?
When the EU was established, the goal was to create a single market, and to support this they worked towards standardization within the producers for that market. This standardization policy tries to ensure that there is an equality between complementary products and services. EU harmonization is an effort to meet this standardization policy and, in order to do this, the EU has issued a listing of standards that support EU organizations in their ability to meet EU regulations in all industries.
What are harmonized standards?
A technical standard is a documented set of requirements used to establish the norm for a repeatable technical task, processes, or technical criteria. In short, these standards tell you what needs to be included to meet an acceptable benchmark, such as the use of ISO 13485:2016 for a medical device Quality Management System.
The European Committee for Standardization is the association that was created to bring together the National Standardization Bodies of 34 European countries to develop the platform to develop standards and other technical documents. The intent of the standards that are developed is to help companies to provide products, services, and processes in a standardized way throughout the EU, and to provide a common way to demonstrate that relevant EU legislation is met.
The 12 main categories of EU harmonized standards are:
- accessibility,
- chemicals,
- conformity assessment and management systems,
- construction,
- consumers and workers protection,
- energy efficiency,
- electric and electronic engineering,
- healthcare engineering,
- measuring technology,
- mechanical engineering and means of transport,
- services, and
- sustainability.
You can learn more about all EU harmonized standards at https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en.
Medical device standards
Within many of these main categories, there are sub-categories of standards; for instance, in the healthcare engineering category there is an area on medical devices that includes over 250 different standards for medical devices that align with the EU council directive 93/42/EEC on medical devices. These standards are compiled to give companies guidance on a standardized method to meet the EU regulations, and include many product standards for the different medical devices that could be manufactured or sold in the EU. You can see the EU harmonized list for medical devices at https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.LI.2020.090.01.0001.01.ENG&toc=OJ:L:2020:090I:TOC.
One important point to note is that on this list for medical devices, ISO 13485:2016 is the only recommended Quality Management System standard for medical device manufacturers. However, why use this standard? Is there another way to implement a QMS for medical devices?
While it is possible to just meet the requirements in the EU MDR, by using ISO 13485 to implement your QMS you will have an internationally recognized management system that fully meets the requirements in paragraph 9 of article 10 of the EU MDR legislation.
Are European standards mandatory?
In short, not always. Some technical standards will need to be followed, but for standards such as ISO 13485 for a Quality Management System, the European Union has indicated that any manufacturers, or other organizations, may choose any technical solution that they wish to demonstrate compliance with the mandatory legal requirements. However, even though these European standards are voluntary, all notified bodies within the EU are asking for compliance with them. In the EU MDR, in Annex II section 4 c, it is stated that demonstration of conformity shall include the harmonized standards, CS, or other solutions applied. So, it is expected that manufacturers will follow the harmonized standards as much as possible.
You can find out more on using ISO 13485 to meet the MDR regulations in the article: How can ISO 13485 help with MDR compliance?
Use harmonized standards to your advantage
Since ISO 13485 is the only standard on the EU harmonized list for a Quality Management System for medical devices, even if it is not mandatory to use, it makes much more sense to use a standard that is recognized worldwide as the industry standard rather than another standard that might not have as wide of an acceptance. The ISO 13485 standard will not only fully meet your legal needs, but also help you to improve in a systematic way.
To find out more about the benefit of using ISO 13485 to create the QMS in your medical device manufacturer, see this free Why ISO 13485? – Awareness Presentation.
