Maria Oliveira is a Trainee Solicitor who attended the University of Law and BPP University.

Contact: Email

Further to our discussion on the European Commission’s proposal to extend the transition period under the Medical Devices Regulation (EU) 2017/745 (MDR), the Commission has adopted a formal proposal for a legislative amendment of the MDR and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) and published a press release, Q&A and factsheet

It’s all happening in the device space. Further to the European Commission’s meeting we discussed last week on the proposed three-year extension to the transition period under the Medical Devices Regulation (EU) 2017/745 (MDR), the EU Medical Device Coordination Group (MDCG) has now published guidance clarifying the use of the non-compliance procedure under Article 97 of the MDR.

Under Article 97, competent authorities can temporarily allow devices that do not comply with the MDR to continue to be placed on the market if they do not present an unacceptable risk to the health or safety of individuals or to public health.

Continue Reading New Guidance on the Application of Article 97 of the MDR to Legacy Devices Certified under the MDD or AIMDD

On the 27 October 2022, the Court of Justice of the EU (“CJEU”) issued a preliminary ruling  regarding the definition of foods for special medical purposes (“FSMP”).  The CJEU held that for a food product to be classified as an FSMP, it must cover the increased or specific nutritional requirements caused by the disease.  It is not sufficient that the product counteracts the disease or alleviates its symptoms, as that would blur the lines between foods and medicinal products. 

1. Background to the Dispute

This ruling arose in the context of an action brought by Verband Sozialer Wettbewerb e.V. (“VSW”) against Orthomol pharmazeutische Vertriebs GmbH (“Orthomol”) regarding two Orthomol products classification as FSMPs.  This action was brought before the Landgericht Düsseldorf (Regional Court, Düsseldorf, Germany) at the first instance and was then appealed to the Oberlandesgericht Düsseldorf (Higher Regional Court, Düsseldorf, Germany) which then referred the case to the CJEU for a preliminary ruling. 

Continue Reading CJEU clarifies the Food for Special Medical Purposes Definition