EU: EU Commission updates its lists of harmonized standards
The European Commission has updated its lists of harmonized standards. Among others, the following standards were harmonized:
- EN ISO 15223-1:2016, on the use of these symbols in the labelling of and information supplied with products, will supersede its predecessor, EN 980:2008, on December 31, 2017
- EN ISO 13485:2016 on quality management system requirements for regulatory purposes. This standard, which appears in all three lists, will supersede EN ISO 13485:2012 on March 31, 2019.
- Revised standard EN 60601-2-33:2010, which addresses requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis, will replace its predecessor on December 31, 2017
For the lists of the harmonized standards please see:
- Commission communication in the framework of the implementation of the Council Directive 93/ 42/EEC concerning medical devices
- Commission communication in the framework of the implementation of Council Directive 90/385/ EEC on the approximation of the laws of the Member States relating to active implantable medical devices
- „Consequences of the Medical Devices Regulation (MDR) for Notified Bodies and Manufacturers” Interview with our Managing Director, Klaus-Dieter Ziel for the MPJ- Journal for Medical Devices
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- EU: Designation Process for Notified Bodies under the MDR
- EU: EU Commission updates its lists of harmonized standards
- MEDCERT: Application for the Designation as Notified Body under the MDR – Medical Device Regulation