Spanish Agency for Medicine and Health Products (AEMPS) regulates the quality, efficiency, and safety of medical devices(MD) in Spain. The agency regulates and certifies pharmaceuticals for humans and animals in addition to monitoring supplies and certifying medical devices.
Spain has a population of over 47 million and the fourth largest economy in the European Union(EU). Public health care accounts for over 80% of the demand for medical devices At the same time, the demand for private health care has increased considerably with the widespread pandemic. The primary export destination from Spain is within the EU, over 60% to Germany, Portugal, Belgium, France and Italy.
Medical devices are divided into four classes: I, IIa, IIb, III.
Class I – Medical devices (already marketed in other European Union countries) can be placed immediately without going through the Regulatory Authority.
Classes IIa, IIb, III – Medical devices must have the EU conformity mark(CE) indicating manufacturer’s compliance with regulations and technical standard ISO 13485:2016.
May 26, 2021, all EU countries including Spain will adopt the new Regulation 2017/745 on medical devices.
Class IIa, IIb, II – Medical devices from EU manufacturers and European Authorized Representatives (EU REP for non-EU). Includes all others involved in marketing Class IIa, IIb, and III devices who must notify the Regulatory Authority. Submit documentation documentation in Spanish including CE certificate, labelling, and instructions through the Comunicación de Comercialización de Productos Sanitarios(CCPS) online portal. (Implant card required for implantable devices.) The costs and time required for obtaining the CE may vary. After notification is sent, the CE marked
device can be placed immediately on the market. The device remains in the CCPS database up to 5 years (no extra fees). Renew ISO 13485 certification annually.
Spain encourages the Voluntary Harmonization Procedure(VHP) which is submitted in advance of the official complete research file. VHP submissions require two or more EU states to apply for an informal clinical assessment. The purpose of a VHP is to identify any problems in the formal clinical research study before its submission. Results include assessment of regulations of devices used in a health care facility, in single use devices, and implant devices. The process moves faster with a VHP submission, averaging 90 days, than it would in EU states without the VSP.