EDMA Publishes a Position Paper on New EU IVD Regulation

In 2012, the European Commission proposed draft text for a new EU IVD regulation to replace the IVD directive 98/79/EC. Since publication, the text has undergone rounds of negotiation and revision, with the latest amendments being made by the European Council in June 2015.

The European Diagnostic Manufacturers Association (EDMA) has expressed concerns about the latest amendments to the proposed regulation put forward by the European Council in June 2015. In a position paper published on August 25th 2015, EDMA outlined six key areas of the draft regulation they believe require further attention.

  • Clinical Evidence
  • Conformity Assessment
  • Quality Management Systems
  • Companion Diagnostics
  • Classification
  • Labelling Requirements

EDMA raised concerns that the European Council’s general approach of June 2015 contains a ‘significant amount of technical anomalies’ and states that ’the regulation as proposed would put an excessive and unnecessary administrative burden on SMEs’.

The next stage in the approval process is a trilogue negotiation between the European Parliament, Council and Commission, after which the final text will be adopted, possibly in Q1 or Q2 of 2016

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