On 25 October 2018, the Court of Justice of the EU (CJEU) held in Case C-527/17 Boston Scientific that, where a medical device incorporates an ancillary drug substance, that substance will not be entitled to supplementary protection certificate (SPC) protection. That is the case even if the drug substance has been subjected to an evaluation of its safety, quality and efficacy that is analogous to the authorisation procedure for medicinal products, which are entitled to SPC protection.

Continue Reading European Court ruling on SPCs for medical devices

Software can be considered a medical device under EU law. Although guidance has been issued by the European Commission and national authorities to assist in legal classification, factors or criteria that are considered as relevant in such guidance have not been validated by European or national courts. The recent decision of the Court of Justice of the European Union (CJEU) on legal classification of software medical device is therefore instructive.

The European Court’s first decision on the classification of software in the context of medical devices legislation

On 7 December 2017, the CJEU issued its judgment in Case C-329/16. The CJEU agreed with the Advocate General’s opinion (discussed in our previous Advisory), and held that software can be classified as a medical device under EU law if the software has at least one functionality that allows the use of patient-specific data to assist the physician in prescribing or calculating the dosage for treating the underlying condition. It does not matter whether the software acts directly or indirectly on the human body. The decisive factor is whether the software is specifically intended by the manufacturer to be used for one or more medical objectives specified in Article 1(2) of Directive 93/42/EEC (the Medical Devices Directive), including the diagnosis, prevention, monitoring, treatment or alleviation of disease.

Continue Reading Classification of software as a medical device