The European Commission has published an updated version of harmonized standards that devicemakers and diagnostics makers can reference to ensure their products comply with relevant EU legislation.
The standards are an update to those implemented by the European Council’s Directive 93/42/EEC in 1993.
In the directive, changes are listed under categories for implantable, medical and in-vitro devices. When standards have been updated, manufactures need to re-evaluate their products against the updated standards and provide an updated version of their Declaration of Conformity. The date of implementation is June 30 unless otherwise noted.
Here are some of the important updates:
Medical Electrical Equipment: