European Commission Adopts Revised Standards to Speed Devices to Market

Regulatory NewsRegulatory News | 26 March 2020 |  By 

As part of work to facilitate a faster and less expensive conformity assessment procedure for those marketing certain medical devices, the European Commission earlier this week adopted revised harmonized standards.

The commission's implementing decisions relate to the medical devices, in vitro diagnostics and active implantable medical devices directives. The revised standards are meant to speed the production of medical face masks, gloves, containers for intravenous injections, sterilization devices and disinfectants and alter particular requirements for emergency and transport ventilators, among others.

As part of joint efforts to combat the coronavirus pandemic, the commission, CEN and CENELEC also agreed to make a number of the harmonized standards for medical protective equipment, like face masks and single-use gloves, freely available to companies that want to start producing them.

“Once agreed and referenced in the Official Journal of the European Union, these harmonised standards become part of EU law and allow companies an easy and direct access to the internal market for their products, while ensuring a high degree of safety for users and consumers,” the commission said.

Official Journal of the European Union

Coronavirus: harmonised standards for medical devices to respond to urgent needs


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