C-527/17 ruling is out: No SPCs for CE-marked devices

The CJEU handed down its ruling on C-527/17 (Boston Scientific)- available here.  It decided:

Article 2 of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that a prior authorisation procedure, under Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007, for a device incorporating as an integral part a substance, within the meaning of Article 1(4) of that directive as amended, cannot be treated in the same way, for the purposes of applying that regulation, as a marketing authorisation procedure for that substance under Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004, even if that substance was the subject of the assessment provided for in the first and second paragraphs of section 7.4 of Annex I to Directive 93/42, as amended by Directive 2007/47.

In essence, the CJEU has ruled that a CE-mark approval for a medical device comprising an active ingredient as an integral part cannot be considered as an approval in accordance with the Medicinal Products Directive, even if the ingredient was assessed using the consultation process.

Many thanks to Oswin Ridderbusch and Alexa von Uexkuell (Vossius & Partner) for spotting the ruling!