A harmonized standard is a European standard developed by the following recognized European Standards Organizations: CEN, CENELEC, or ETSI. Manufacturers and conformity assessment bodies use harmonized standards to demonstrate products or processes comply with the relevant EU legislation.
The references for the harmonized standards are published in the Official Journal of the European Union (OJEU). There are new references of harmonized standards for medical devices, active implantable medical devices and in vitro diagnostic medical devices. The use of the standards is voluntary. Manufacturers and conformity assessment bodies may use alternative standards or solutions to prove compliance of their products.
The EU Commission updates the lists of references of harmonized standards and publishes new references in the OJEU on second Friday of each month.
Here are the latest references:
- Medical Device Directive, 93/42/EEC – 10 new references
- Active Implantable Device Directive, 90/385/EEC – 2 new references
- In Vitro Diagnostic Device Directive, 98/79?EC – 3 new references