The Swiss Federal Office of Public Health issued an update on the alignment of the country’s medical device legislation with the new EU requirements adopted early last year.
Although not an EU member, Switzerland is part of the European Free Trade Association and wants to ensure that its device manufacturers continue to have full access to the EU market.
Revisions to the country’s Therapeutic Products Act and to the Human Research Act will be followed by a complete overhaul of its Medical Devices Ordinance and a new ordinance for in vitro diagnostics.
In force since Jan. 1, 2002, the Medical Devices Ordinance integrated the European medical devices directives on active implants, classical and in vitro diagnostic devices into Swiss law.
Revisions in April 2010 harmonized the Swiss law with the EU’s revised medical devices directives, and requirements for conformity assessment bodies were increased as of Apr. 15, 2015 to align with those of the EU.
The regulatory authority is inviting comments on the proposed amendments by June 11, 2018. Entry into force of the legislative changes is scheduled for the first half of 2020.
The new regulations for medical devices and in vitro diagnostics will introduce stricter requirements, making manufacturers prove the effectiveness of high-risk devices through clinical studies on a more frequent basis.
In addition, criteria for clinical trials and performance testing will be strengthened, and the EU now expects clear identification of all devices to allow full traceability.
The regulations also require that relevant data to be made available to the public by means of Eudamed, the centralized European databank for medical devices.
The adjustments to the Swiss medical devices law will occur in stages, in line with the transitional periods that apply to the EU member states. — James Miessler