Regulation and Product Standards

Regulation and product standardsIn Europe the import and manufacture of medical devices is regulated by the European Union's Medical Device Directive 93/42/EEC. This Directive is in place to ensure that medical devices sold in Europe will not be harmful or pose any health risk. The EU Commission is considering a Recast of this Directive. Public consultations took place in 2008 and 2010. A high-level stakeholders’ conference was organised in March 2011. This conference was followed up by Conclusions of the EU Council on innovation in the medical device sector, adopted on 6 June 2011. Adoption of the Recast Directive is expected in 2012.

As well as this Directive, there are various European Pharmacopoeia Monographs for polymeric materials. The two specific monographs for flexible PVC are 3.1.1 'Materials based on plasticised polyvinyl chloride for containers for human blood and blood components and for containers for aqueous solutions for intravenous infusion' and 3.1.2 'Materials based on plasticised polyvinyl chloride for tubing used in sets for the transfusion of blood and blood components'.

The European Pharmacopoeia, in force from January 1,1999, provides strict regulation concerning the absence of any physiological hazard in pharmaceutical packaging made from rigid PVC.

These monographs give guidance on both the chemical compositional requirements of components for medical devices as well as chemical toxicity testing for potential extraction of either inorganic or organic contaminants. Medical devices which involve blood storage generally have the most demanding criteria.

In addition to these monographs there are a wide range of international quality standards to which products must comply. Biological testing criteria are covered in EN/ISO10993 'Biological Evaluation of Medical Devices'. Additionally, many devices manufactured in the EU also have to conform to other international criteria such as the United States Pharmacopoeia XXIII.