The European Union relies increasingly on technical standards for harmonisation in the single market.
A landmark decision by the European Court of Justice (ECJ) has now been handed down on this: the technical standards concerned must be accessible free of charge to companies and citizens.
For medical device manufacturers this is good news, but with few immediate benefits: not all standards relevant to medical device manufacturers are harmonised. While EN ISO 13485 is harmonised, for example, other important standards relevant to medical device manufacturers will continue to be subject to a fee.
A list of all standards for medical devices harmonised under the MDR is available here and can also be downloaded in Excel or PDF format: https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards/medical-devices_en
Heise online reported on it: https://www.heise.de/news/EuGH-Entscheid-Europaeische-Normen-muessen-gratis-zugaenglich-sein-9646757.html