On February 26th of 2019 a CEN Webinar about Good practices for the development of harmonised standards under the Medical Device Directive. UNE, as member of the MIRACLE Project, has attended to have first-hand information to be taken into consideration during the development of project.
It is important to highlight that the previous Medical Device Directive (93/42/EEC) and Active Implantable Medical Devices Directives (90/385/EEC) have been revised and unified in the Medical Devices Regulation (2017/745) that entered into force in May 2017. At this moment the three regulations are in a coexisting period that will finalize in one year, on May 26th 2020, date on which the two directives will be repealed and the Regulation will be the only applicable act.
In consequence, the harmonized standards under the Medical Devices Directives are under revision. For that, a Standardization Request is under development in the European Comision. Its priority will be the following standards:
- EN ISO 13485 on quality management system,
- EN ISO 14971 on risk management,
- EN ISO 15223 on labelling symbols,
- EN ISO 14155 on clinical investigation,
- EN ISO 10993 on biological evaluation,
- EN 60601 on medical electrical equipment.
All of them relevant for the process of development of a new medical device, as it is the objective of the MIRACLE Project.