New EU IVD Regulations, Potentially In Line with Australian IVD Requirements

The European Commission is considering a number of key requirements, namely classification rules and clinical evaluation, for inclusion in the new IVD Regulation which will be potentially implemented in the European Union (EU) during 2015/2016.   These requirements echo changes made to the Therapeutic Goods (Medical Device) Regulations 2002 as amended which are specific to IVDs.

One of the proposed changes to the current IVD requirements is the introduction of 10 classification rules which will define IVDs as Class A, B, C, or D (Class D being the highest risk). The rules are similar to those defined by the Global Harmonisation Task Force (GHTF) risk based and conformity assessment guidance although the rules would be more specific.  The rules set out for Australian IVD compliance are very similar to the planned EU IVD Regulation.

Another major change proposed by the European Commission for inclusion in new the IVD Regulation is a requirement for clinical evaluation for all IVDs excluding the lowest class (Class A products). This is a significant change from current practice which calls for clinical evaluation for specific high risk IVDs only. Despite this, the change surprisingly has not proved unwelcome within industry. Under the proposed regulation, manufacturers would be expected to provide a clinical report which included evidence of scientific validity, analytical performance, intended purpose, and clinical performance; again, requirements which are not unlike the Australian requirements.

The potential EU changes, whilst not imminent, are a blessing for IVD manufacturers who are and will be working with new Regulation in a number of key markets. The gap in documentation currently required for Australia and that which manufacturers hold for EU compliance will be notably reduced. It is hoped this will result in lesser burden on overseas manufacturers wishing to place product on the market in Australia.

For assistance understanding or complying with Australian IVD requirements, contact KD&A.