The CE marking of medical devices has been mandatory since it came into effect in 1998. The Directive 93/42/EEC of the European Union establishes the requirements for the import and commercialization of medical devices.
Spanish legislation incorporates the European directive in Royal Decree 414/1996, which defines what is meant by a medical device and establishes its different types.
The conformity assessment procedures can vary depending on the type of product. To obtain the CE marking for medical devices, prior conformity according to the regulations must be achieved.
Types of Medical Devices
Medical devices are classified into three main classes, plus a fourth type that includes custom-made and investigational devices. Importers must obtain conformity for the CE marking of medical devices according to this classification.
CLASS I
This category includes low-risk medical devices, non-invasive, and not in permanent contact with the skin or mucous membranes. For their importation, only a certificate of conformity is required. This group includes bandages, elastic stockings, and walkers, among others.
Within this class, there is a subtype that includes sterile products, which require a certificate of conformity plus production quality assurance. These products include syringes, reusable surgical instruments, and examination gloves.
Products such as non-electronic thermometers and tonometers are considered Class I medical devices with a measurement function. These require a certificate of conformity, production and product quality assurance, and CE verification.
CLASS II
Class II is subdivided into two types: Class IIa and Class IIb.
Class IIa covers moderate-risk medical devices, temporarily invasive and without significant effect on the body. For their import and distribution, the CE marking of medical devices with a certificate of conformity, production and product quality assurance, CE verification, and a total quality system is required.
This CE marking is necessary for product disinfectants, single-use scalpels, hearing aids, contact lenses, cannulas, etc.
Class IIb products are considered high-risk because they are long-term invasive, have effects on the body, or serve for the diagnosis of vital functions.
The CE marking of Class IIb medical devices is obtained with a CE examination plus production and product quality assurance, CE verification, and the total quality system.
This procedure is necessary for contraceptives, condoms, disinfectants for invasive products, intraocular lenses, and contact lens care products, among others.
CLASS III
These are high-risk products, invasive and potentially life-threatening. This group undergoes the most complex procedure. To obtain the CE marking of medical devices, they require an additional design examination. This is necessary for absorbable sutures, stents, prostheses, heart valves, etc.
Custom-Made or Investigational Medical Devices
The last group includes custom-made or investigational medical devices. This class requires a conformity declaration for products with a special purpose.
The Spanish Agency of Medicines and Medical Devices (AEMPS) has translated and published two documents with the most frequently asked questions about the transitional provisions for the application of the regulations relating to the CE marking of medical devices.
Furthermore, to import medical devices, a health license issued by AEMPS is required and special facilities must be available, overseen by a healthcare technician.
Since this is a complex topic, we always recommend our clients conduct a study of the legal requirements for each case. If you wish to import medical devices or cosmetics, contact Bull Importer, and we will handle all the procedures.
