Examples of Applicable regulatory requirements

Each medical device must be designed and manufactured in accordance with the relevant technical standards. Given the variety of medical products (from the spoon for giving antibiotics to the artificial heart), it is clear that the same standards do not apply to all medical products. So it is the responsibility of the manufacturer to determine what the additional standards are that apply to his product. Some of such standards are e.g. EN 12470 for clinical thermometers, or EN 12184 for electrically powered wheelchairs, or EN ISO 11608 for needle-based injection systems.

Furthermore, certain standards refer to some procedures such as standards covering sterilization. Given the different methods of sterilization, there are dozens of standards associated with sterilization. Again, it is the responsibility of the manufacturer to determine which sterilization standards must be met. 

According to the Medical device regulation (MDR 2017/745), all manufacturers of medical devices must comply with the so-called harmonized standards or state-of-the-art standards (Article 8 – Use of harmonized standards).

For more information, see:

• EU MDR Article 8 – Use of harmonised standards - https://advisera.com/13485academy/mdr/use-of-harmonised-standards/

The link to the harmonized standards published in the Official Journal of the European Union 24-03-2020 is following: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2020:090I:TOC

with an amendment from 14-04-2021: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2021.129.01.0153.01.ENG

For more information about What are EU harmonized standards please see the following link:

• What are EU harmonized standards? https://advisera.com/13485academy/blog/2020/06/12/what-are-eu-harmonized-standards/