Draft text of new Spanish regulation on medical devices is opened for contributions

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The Spanish Ministry of Health has initiated the hearing and public information process for the new regulation on medical devices. The draft text will be available for contributions by 10 July 2021.

The direct application of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR) requires the alignment of the local legislation on medical devices currently in force. In this respect, the new regulation aims to: (i) repeal the existing legal texts on medical devices (Royal Decree 1591/2009) and active implantable medical devices (Royal Decree 1616/2019); (ii) develop the necessary regulatory measures for those aspects where the MDR has determined that it will be the Member States that will regulate at national level; and (iii) adapt, adopt or maintain the measures required by national law.

As we have previously discussed, the MDR, among other issues:

  • harmonizes the rules applicable to the placing on the market and putting into service in the EU of medical devices, allowing them, therefore, to benefit from the principle of free movement of goods and ensuring a high level of protection;
  • consolidates the regulatory approach applicable to a number of relevant areas, such as the supervision of notified bodies, conformity assessment procedures, clinical investigations and clinical evaluation, or market surveillance and control;
  • introduces provisions to ensure the transparency and traceability of medical devices;
  • lays down certain groups of non-medical devices which should also fall under its scope of application due to their similarities to medical devices in terms of performance and risks; and
  • develops the obligations of the various economic operators, including distributors and importers, and establishes the procedure for consultation of panels of experts.

Although the MDR is directly applicable in the EU countries, there is a need to regulate at national level those aspects that the EU standard leaves to the regulation of each Member State. Thus, the new text specifies issues such as (i) the determination of the competent authority for the purposes of the MDR, (ii) the health guarantees of the devices, (iii) the regulation of the procedures for the manufacture of devices for use in health centers and for the reprocessing of single-use products and their use, (iv) the language regime, or (v) certain aspects relating to clinical investigations in Spain.

The draft regulation consists of the relevant preamble, nine chapters, 41 articles, three additional provisions, one repealing provision and three final provisions. Broadly speaking, and apart from the aforementioned, the new text aims to regulate medical devices from human use and their accessories and non-medical devices and, in particular: (i) health guarantees; (ii) procedures for granting prior licenses to operate facilities; (iii) requirements and actions of notified bodies; (iv) placing on the market and putting into service in Spain; (v) reprocessing of single use products; (vi) intra-Community and foreign trade; (vii) clinical investigation; (viii) surveillance system; and (ix) market inspection and control and health protection measures; all conveniently adapted to the MDR.

The new text creates new administrative burdens not foreseen by the previous legislation. Thus, some of these charges correspond to new activities, such as reprocessing of single-use products and manufacturing of products in hospitals, which will require a prior operating license. Similarly, prior operating license will be required for third-party manufacturers and for manufacturers of non-medical devices listed in Annex XVI to the MDR. In addition, the obligation to notify the registration of placing on the market of Class I medical devices and non-medical devices in Annex XVI to the MDR is introduced.

Last but not least, the draft regulation does not cover matters relating to the advertising, promotion, incentives, and sponsorship of scientific meetings, which will continue to be subject to the previous rules. This is due to the fact that the Ministry of Health is currently working on a draft regulation specific to advertising of medical devices, which is expected to repeal the existing regime when the new legal framework takes effect.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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