Dec 15, 2010

MEDDEV 2.7/4 on clinical investigations is available on the European Commission website, and also in Emergo’s extensive Learning Library along with other important documents.

The new guidelines address the requirements of Annex X of directive 93/42/EEC and Annex VII of directive 90/385/EEC (as amended by directive 2007/47/EC) and are based on the GHTF document SG5/N3:2010.

This is the first MEDDEV published on Clinical Investigations. These guidelines offer clarifications on conformance with EN ISO 14155-1:2009 and EN ISO 14155-2:2009 for clinical investigations, and on meeting the Essential Requirements of the relevant directives.

The document provides guidance primarily on two points: 1) when clinical investigations would be needed to show compliance with relevant Essential Requirements and, 2) general clinical investigation principles for medical devices. As is the typical approach with MEDDEV guidance, general recommendations and interpretations are offered rather than detailed coverage of investigative procedures. Guidance on clinical studies of in vitro diagnostic (IVD) devices is not covered in MEDDEV 2.7/4.

Details of this new guidance document are addressed at greater length on the Emergo Group blog.

EU Court of Justice Ruling

The European Union Court of Justice recently ruled that internet sales of medical devices cannot be banned outright by member states, although restrictions can be applied in proportion to the needs required to ensure public safety.

The case was brought before the court to challenge Hungarian legislation that prohibited internet sales of contact lenses.

In the Court’s opinion, Hungary’s prohibition of online sales of contact lenses impedes the free movement of goods through the EU because the law affects, not only Hungarian merchants, but any European business selling similar products online to Hungarian customers. Further, Member States’ national legislation regarding whether vendors may sell devices online must be in accord with the e-commerce directive (Directive 2000/31/EC).

An important clarification was made regarding the scope of the e-commerce directive; the court clarified that online sales of medical devices fall within the purview of the directive based on the rationale that they are not explicitly excluded by it.

This ruling has important implications for online sellers of medical devices. The clarification that medical devices are covered by the e-commerce directive and, thus, cannot be prohibited by Member States will give online sellers added legitimacy and a stronger standing throughout the EU.

Full text of the ruling is available from the Court of Justice of the European Union’s website.


  • Stewart Eisenhart