The EU new Medical Device Regulation (MDR) could be ready for adoption as early as by the end of 2015. Although it is more realistic to think the new regulations will be ready to be implemented in early 2016, it is important that all Australian manufacturers and exporters to the EU are aware of the changes currently taking place with the medical device regulations in the EU. The new MDR proposes to replace the current Medical Device and IVD Directives. The main points that are currently being evaluated by the European Commission are: The EU new Medical Device Regulation (MDR) could be ready for adoption as early as by the end of 2015. Although it is more realistic to think the new regulations will be ready to be implemented in early 2016, it is important that all Australian manufacturers and exporters to the EU are aware of the changes currently taking place with the medical device regulations in the EU. The new MDR proposes to replace the current Medical Device and IVD Directives.   The main points that are currently being evaluated by the European Commission are: 1. Notified Bodies to answer to competent authorities of the Member States. 2. Centralised Post-market safety system. 3. Involvement of external expertise in the regulatory processes. 4. Efficient and effective regulatory system management. Some more specific issues within the main points are: 1. Regulatory gaps or uncertainties that currently exist with regarding certain products. For example: Products manufactured utilising non-viable human tissues or cells, implantable or other invasive products without a medical purpose, The reprocessing of single-use devices which are currently not regulated by the EU legislation on medical devices. In the field of IVDs, “in-house” tests are currently exempted from the IVD Directive but the application of the exemption diverges amongst the … Continue reading EU New Medical Device Regulation 2016