The directive 98/79/EEC on in-vitro diagnostics (IVD) sets the current legal framework for in-vitro diagnostics in the European Economic Area. In 2011 a proposal for an European-wide harmonized “legal decree” on in-vitro diagnostics was introduced from the European Commission.
That means that the old directive (in-vitro diagnostics directive) will be replaced by an European decree, which will be become effective in all member states of the European Economic Area, without making a national act being necessary for transposition. The new decree strengths the European Commission in their own rights and makes changes in regulations e.g. new classification rules for particular medical devices possible, even on a short term.
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