EU Medical Device Regulation (MDR) - Summary of Timeline & 9 Pointers
Both the Council Directive 93/42/EEC (MDD) and Council Directive 90/385/EEC (AIMDD) will transition into the Medical Device Regulations...
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ARQon
Dec 18, 20182 min read
EU In vitro Diagnostic Regulation (IVDR) - Summary of Timeline & 9 Pointers
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...
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ARQon
Dec 11, 20181 min read
Key Endorsements in the 7th AMDC Meeting
The AMDTC is working on the following two key work items: Classification of products as Medical Device or Non-Medical Device in the...
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ARQon
Nov 5, 20181 min read
Europe - Dec 2018
EU: UDI guidance documents developed by the MDCG to support implementation of MDR EU: Basic guidance issued for manufacturers on...
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ARQon
Sep 4, 20181 min read
Europe - Aug/Sep 2018
EU: Manual on borderline and classification issues updated France: Decree on summary of characteristics for Class III/implantable devices...
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ARQon
Sep 4, 20181 min read
Drugs - Aug/Sep 2018
International - ICH Guidelines Implementation Australia - Medical Devices Safety Update, Volume 6, Number 4, Jul-2018 China - CDE...
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ARQon
Aug 30, 20183 min read
EU Notified bodies release Action date for MDD CE mark renewal while waiting MDR
European Union: The countdown until the EU Medical Device Regulation (MDR 2017/745 EU) takes hold in late May 2020 is heating up. While...
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ARQon
May 23, 20181 min read
Europe - May 2018
EU/UK: Withdrawal of the UK and EU rules in the field of industrial products EU: Commission proposes Member State cooperation on Health...
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ARQon
May 23, 20181 min read
Drugs - May 2018
International - Press Release of the PIC/S Committee Meeting in Geneva (Switzerland), May-2018 Australia - Australian Regulatory...
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ARQon
Feb 12, 20182 min read
Drugs - February 2018
International - WHO Drug Information, Volume 31, No. 4 International - EDQM Press Release: The Ph. Eur. Revised its General Chapters on...
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ARQon
Feb 2, 20181 min read
Europe - February 2018
EU: Codes and corresponding device types, application forms, and application documentation for Notified Body designation EU: Conditions...
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ARQon
Jan 1, 20181 min read
Europe - December 2017
EU: Codes and corresponding device types, application forms, and application documentation drafted for NB designation EU: Products whose...
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ARQon
Jan 1, 20181 min read
Drugs - December 2017
US: Mepergan Fortis Capsules; Final Decision on Proposal to Refuse Approval of Supplemental New Drug Application; Availability of Final...
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ARQon
Nov 1, 20172 min read
Drugs - October 2017
US: Minimal Manipulation and Homologous Use Products US: Manufacturers Sharing Patient-Specific Information from Medical Devices with...
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ARQon
Aug 24, 20171 min read
Europe - May 2017
Europe: European Parliament adopts new medical devices and in vitro diagnostics Regulations Europe: Court of Justice delivers its...
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ARQon
Aug 24, 20172 min read
Drugs - May 2017
Australia: Guidelines on Compounded Medicines and Good Manufacturing Practice (GMP) Australia: Guidelines on Code of Practice for...
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ARQon
Apr 5, 20171 min read
Europe - April 2017
Europe: Latest timings on the new Regulations for medical devices and IVDs Europe: Products whose principal intended action (depending on...
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ARQon
Apr 2, 20172 min read
Updates on Drugs - April 2017
Australia: Strengthening Monitoring of Medicines in Australia Canada: Notice: Guidance Document - Fees for the Right to Sell Drugs...
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ARQon
Aug 1, 20161 min read
Using IEC 60601-1-9 as a Competitive Advantage
Download this white paper to learn how IEC 60601-1-9 can be used to promote sustainability claims for your medical devices including:...
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ARQon
Aug 1, 20161 min read
Medical Device Regulation Finally Published
The consolidated final draft of the new Medical Device Regulation (MDR) has recently been published. The new regulation shall replace the...
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