Proposed New European Medical Device Legislation

ISO 13485In September 2012 the European Commission adopted a proposal for the regulation of medical devices; this regulation will replace the medical device directive (MDD 93/42/EEC).

Changes to the MDD had been discussed for some time but following the breast implant scandal at French company Poly Implant Prothese (PIP) European regulators came under increasing pressure to toughen controls for medical device manufacture and distribution.

The use of regulations instead of directives is important because regulations are directly in force across all countries in the EU, whereas directives must be transposed into national law in each member state. The transposition process led to variations in the implementation of the directive this will now be avoided by the use of a regulation type approach. The regulatory approach is how the Pharmaceutical industry operates within the EU.

The proposed regulations must now be submitted for review by the European Parliament and European Council, this process will take at least 12 months to complete. Once the final wording for the regulation is published manufactures will have three years to comply with the new requirements. The Almir Newsletter will be publishing further articles throughout 2013 on the impact the new medical device regulations will have for medical device manufactures.

If you have any queries on how the proposed medical device legislation could impact on your business please contact us on 061 514 598.