Both the Council Directive 93/42/EEC (MDD) and Council Directive 90/385/EEC (AIMDD) will transition into the Medical Device Regulations...

The IVDR is set to replace the IVDD in order to adapt to more technical/scientific requirements for IVDs to be placed in the EU...

The AMDTC is working on the following two key work items: Classification of products as Medical Device or Non-Medical Device in the...

EU: UDI guidance documents developed by the MDCG to support implementation of MDR EU: Basic guidance issued for manufacturers on...

EU: Manual on borderline and classification issues updated France: Decree on summary of characteristics for Class III/implantable devices...

International - ICH Guidelines Implementation Australia - Medical Devices Safety Update, Volume 6, Number 4, Jul-2018 China - CDE...

European Union: The countdown until the EU Medical Device Regulation (MDR 2017/745 EU) takes hold in late May 2020 is heating up. While...

EU/UK: Withdrawal of the UK and EU rules in the field of industrial products EU: Commission proposes Member State cooperation on Health...

International - Press Release of the PIC/S Committee Meeting in Geneva (Switzerland), May-2018 Australia - Australian Regulatory...

International - WHO Drug Information, Volume 31, No. 4 International - EDQM Press Release: The Ph. Eur. Revised its General Chapters on...

EU: Codes and corresponding device types, application forms, and application documentation for Notified Body designation EU: Conditions...

EU: Codes and corresponding device types, application forms, and application documentation drafted for NB designation EU: Products whose...

US: Mepergan Fortis Capsules; Final Decision on Proposal to Refuse Approval of Supplemental New Drug Application; Availability of Final...

US: Minimal Manipulation and Homologous Use Products US: Manufacturers Sharing Patient-Specific Information from Medical Devices with...

Europe: European Parliament adopts new medical devices and in vitro diagnostics Regulations Europe: Court of Justice delivers its...

Australia: Guidelines on Compounded Medicines and Good Manufacturing Practice (GMP) Australia: Guidelines on Code of Practice for...

Europe: Latest timings on the new Regulations for medical devices and IVDs Europe: Products whose principal intended action (depending on...

Australia: Strengthening Monitoring of Medicines in Australia Canada: Notice: Guidance Document - Fees for the Right to Sell Drugs...

Download this white paper to learn how IEC 60601-1-9 can be used to promote sustainability claims for your medical devices including:...

The consolidated final draft of the new Medical Device Regulation (MDR) has recently been published. The new regulation shall replace the...