The Medical Devices Directive 93/42/EEC defines safety and performance requirements for medical equipment sold in the European Union.
Medical Regulations & Standards
Regulations & Standards
IVD (In Vitro Diagnostics) devices are regulated by EU Directive 98/79/EC of 27. October 1998.
ISO 13485 certification is relevant for all medical devices manufacturers and suppliers.
Medical device manufacturers who want to access the Canadian market must, as part of the requirements to obtain and maintain a medical device license from Health Canada, be registered in accordance
ISO 9001 certification is relevant for all sectors and companies that want to focus competitively on customer needs and product quality.