Medical devices and legal certainty

On May 26^th we will probably have overcome the coronavirus crisis already, but my article today is not about this. It is about the new Regulation 2017/745 on medical devices, which will enter into force on that day. According to its Preamble, the Regulation aims to ensure the proper functioning of the internal market in the EU and to maintain a high level of health protection for patients and users. In the same paragraph, the European legislator says that “the interests of small and medium-sized enterprises that are active in this sector” should also be taken into account. Whenever I encounter a rule that mentions the idea of reconciling public and private interests, I think we are on the right track, because I believe that approaching the regulation of any situation from unnecessarily aggressive positions against companies does not make sense.

With this in mind, do you know what has always been one of the biggest concerns of companies? Something as simple as legal certainty, the absence of regulatory confusion and predictability in the application of the law, to be able to know which law applies. The Regulation, also in its Preamble (paragraph 15), speaks of ensuring a “high level of health protection, free movement of goods and legal certainty for manufacturers”. In paragraphs 20 and 36 there are two further references to the desirability of promoting legal certainty.

Two months before the entry into force of the Regulation, we are not on the right track, and not because of the coronavirus, but because various administrations (both in Spain and in the European Union) have decided to set the criteria on several issues relating to the application of this law using a Q&A document which (at least in its Spanish version) begins with a warning not to be missed: “The information presented in this document is for the purpose of general information only and is not intended to represent legal advice to any individual or entity. It reflects the outcome of discussions within the Transition Sub Group (TSG) of the CAMD… to establish recommendations on the interpretation of transition-related provisions. It is not intended to be a guidance document. We recommend that you should obtain your own legal advice before taking any action based on information given here. The content of this FAQ table will be updated continuously. While we strive to provide the following information in as timely and accurate a manner as possible, this document does not make any claims or guarantees about the accuracy, completeness or sufficiency of its contents.”

Despite this warning, more than one administration is acting as if this Q&A document was the Constitution!