The Spanish Medicinal Products and Medical Devices Agency has approved Circular 3/2012 on Technical Assistance in Medical Devices, which includes certain recommendations for medical devices companies when providing their customers with technical assistance (whether under the manufacturer guarantee or otherwise).
Circular 3/2012, which replaces and supersedes Circular 10/99 of the General Directorate of Pharmaceuticals and Medical, does not make material changes with to the former recommendations.
Therefore, medical devices companies remain subject to the same main obligations when providing technical services:
- Employee qualification/training: the installation, use and maintenance of the medical device can only be carried out by a person and/or entity possessing the necessary knowledge and expertise gained through specialized training and/or practical experience.
- Available means: suitable premises, facilities, equipment, tools and work equipment shall be available to carry out such services in order to ensure the quality, safety and compliance with all applicable regulations.
- Perform controls and safety checks.
- Documentation and Records Keeping: All technical assistance operations or security checks should be recorded in the file of each medical device, specifying the date and the person or entity that performed such activity. Any and all malfunctions and untoward incidents shall also be recorded.
The main changes introduced by Circular 3/2012 are as follows:
- In relation to employee qualification/training requirements: a distinction is drawn between the professional and the specific qualification and such qualifications must be acquired through academic qualification or specific formal training, specific professional accreditation issued by the competent authority or through well recorded practical work experience. The Circular also requires companies to implement a registry which includes the criteria applied in determining such qualification and specifies the training received by each technician, as well as the technical operations for which he is qualified. These records shall be kept by the entity responsible for performing maintenance and shall be available to the competent authority during the term of performance and for at least five years afterwards.
- In relation to the available means: the manufacturer shall provide, together with the medical device, all the information needed to verify whether the device is properly installed and can operate correctly and safely, plus details of the nature and frequency of the maintenance and calibration needed to ensure that the medical device operates properly and safely at all times.