Spain: New regulations for medical devices

By Raquel Ballesteros


On 6 November 2009, two new regulations reshaping the framework for medical devices were published in the Spanish Official Gazette. Royal Decree 1591/2009, on Medical Devices, and Royal Decree 1616/2009 on Active Implantable Medical Devices are the result of the implementation of European provisions (including amendments made by Directive 2007/47/EC to Directive 93/42/EC on Medical Devices) as well as adaptation to national Law 29/2006 on Medicines. These new regulations will come into force from 21 March 2010.  Until then, authorisation, certification and notification proceedings will continue to be carried out according to Royal Decree 414/1996 (the regulation to be repealed by the new regulations).

The medical devices sector is becoming particularly important in Spain, with more than 12,000 operative companies, 30,000 working professionals and a turnover breaking the EUR 6,000 million barrier (8.6 % of European market share). Following these considerations, the new regulation recently passed by the Spanish government pursues several objectives: to implement European legislation; to consolidate rules together within one updated text so as to make compliance easier; and to move towards electronic management procedures thereby reducing administrative burdens for businesses and individuals. But, despite these formal broad statements, it must be remembered that EU legislation leaves little room for Member States to adopt specific rules on medical devices. Accordingly, the regulation laid down by the Spanish government is far from completely new. Indeed, there are no further additions over and above the MD Directive on important issues such as the medical devices essential requirements, classification rules, CE marking procedures and development of medical device surveillance systems.

On the other hand, there are other areas in which the regulations have introduced new aspects:

  • The authorisation procedure for carrying out clinical research using medical devices has been redeveloped. This procedure is quite similar to that for clinical research with medicinal products and is to be followed by the Spanish Medicines Agency, the relevant Ethics Committee and, where necessary, by the regional health authorities.

  • Individuals or companies established in Spain must obtain from the Spanish Medicines Agency an operating license covering activities as well as facilities. Once granted, the license may be denied, suspended or revoked if, upon assessment of documentation provided or inspection reports, there is no assurance that the company has suitable means, facilities, procedures or professionals for the proper development of its activity, or if the conditions in which the license was granted no longer exist.

  • Individuals or companies also have reporting obligations to be carried out before the Spanish Medicines Agency or regional health authorities. This is the case when the individual or company starts its activity for the first time on Spanish territory (in which case, formal notice should be issued to the relevant regional health authority); or whenever a medical device is released for the first time onto the Spanish market (the same individual or company issuing a communication to the Spanish Medicines Agency at the time of the effective release). Finally, together with other cooperation/information/traceability duties to authorities, there are also other important reporting obligations to be complied with concerning medical devices surveillance systems, as well as precautionary measures to be taken directly by the individual or company involved. The information must be addressed in Spanish to the Medicines Agency and, where necessary, to the Regional Health authorities as soon as possible.

  • Other Spanish particularities further to the Medical Devices Directive concern payment of expenditures resulting from non-conformity authorities checking (whenever this check requires carrying out any assessment or clinical trial of the device or its technical documentation); adoption of market restriction measures whenever a health risk is detected (market device withdrawal; retrieving from wholesalers or directly from buyers; devices tracking; etc.); identification upon the Medicines Agency’s request for providers of devices, or wholesalers to whom devices have been sold (this obligation must be upheld for at least five years); distributors must ensure that the device has the CE marking and the device comes with the legal information and any other user information that is legally required. For active implantable medical devices, an `Implantation Card´ is required, including any relevant detail concerning the device itself as well as the applicable surgery it is to be used for.

 Notwithstanding the above, perhaps the most important aspect concerns the distribution, retailing and advertising, and in particular remote retailing and advertising of certain self-testing devices. As a general principle arising from Law 29/2006 on Medicines, remote retailing (either by post or by phone) is not permitted for medical devices subject to doctor’s prescriptions. If a product can be deemed as a self-testing device (within the meaning of Directive 98/79/EC: “Any device intended by the manufacturer to be used by lay persons in a home environment”), then remote retailing would not be permitted at all, except for those devices designed to test pregnancy, fertility and to determine glycemic levels. These same considerations apply with respect to advertising and promotion of self-testing devices. In this respect, article 25.8 of Royal Decree 1662/2000 on Medical Devices for in Vitro Diagnosis (implementing EC Directive 98/79), as amended by 2nd Final Provision of RD 1591/2009, declares that “Advertising and promotion of self-testing devices addressed to general public is hereby prohibited, except for those products concerned with pregnancy and fertility diagnosis. It is also prohibited to advertise genetic diagnosis medical devices”.