On May 30, 2013, Advocate General Sharpston delivered an opinion on a request for a preliminary ruling from the Finnish national courts concerning the laws governing reclassification of medical devices (Advocate General: Opinion, Case C-109/12).  The Advocate General’s opinion does not bind the Court of Justice of the European Union (CJEU).  However, in the majority of cases the Court follows the Advocate General.

National courts use the preliminary ruling procedure if they are in doubt about the interpretation or validity of an EU law. In such cases, they may ask the CJEU for advice. The Advocate Generals provide the CJEU with public and impartial opinions to assist the Court in its decision making. The Advocate Generals’ opinions are advisory and non-binding, but they are nonetheless influential.

The Finnish Supreme Administrative Court sought a preliminary ruling on three questions.  In brief:

  1. Can one Member State classify a product as a medicinal product while another Member State classifies it as a medical device?
  2. What is the process for reclassifying a medical device as a medicine?  Is it sufficient to follow the procedures set out in Directive 2001/83/EC (the Medicinal Products Directive)?  Or is it necessary, prior to initiating procedures under the Medicinal Products Directive, for the competent authorities to follow the applicable provisions of Directive 93/42/EEC (the Medical Devices Directive), particularly Articles 8 and 18?
  3. Can a product with the same active substance and mode of action be on the market in one Member State as both a medicine and a medical device?


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