France: ANSM Designates AFNOR as the Newest Notified Body
Medical devices to be marketed in the European market must obtain CE Marking as proof the devices meet the highest safety, health, and...
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ARQon
Jul 30, 20201 min read
Europe - May 2020
Denmark: New rules mean non-serious adverse events may also need to be reported EU: Application of Regulation (EU) 2017/745 postponed by...
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ARQon
Jun 30, 20201 min read
EU: MDR delayed to 26 May 2021
Application of the Medical Devices Regulation (MDR) has been deferred by one year, until 26 May 2021, for fear of shortage or delay in...
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ARQon
Jan 31, 20201 min read
EU 2020 MDR Guidance Notes For Class I Manufacturers
There will be no transition period for Class I medical devices which remain in Class I under MDR. From 26th May 2020 onwards, the...
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ARQon
Jan 21, 20201 min read
EU: Symbols Guidance for MDR
To comply with new MDR requirements in an efficient manner before the relevant international standard is available, MedTech Europe...
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ARQon
Dec 4, 20191 min read
Europe - Nov/Dec 2019
EU: Commission Implementing Decision (EU) 2019/1396 on the designation of expert panels EU: Industry expresses concerns about proposed...
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ARQon
Nov 7, 20192 min read
EUDAMED delay for 2 years
It was confirmed by the European Commission on 30 October 2019 that the Medical Device Regulation (MDR) EUDAMED will be delayed for two...
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ARQon
Aug 30, 20191 min read
Europe - Aug 2019
Albania: Amendments proposed to ‘Law on Medical Devices’ EU: New MDCG documents on Notified Bodies, the person responsible for regulatory...
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ARQon
Aug 30, 20191 min read
Drugs - Aug 2019
China : NMPA No. 2019/34 Issuance of Provision n Drug Quality Inspection and and Testing EU/US : EMA/FDA Analysis Shows High Degree of...
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ARQon
Jun 28, 20192 min read
Get Ready EU MDR: Factsheet & Step By Step Guide for Manufacturers of Medical Devices, FAQ
Background: The MDR will replace the existing Medical Devices Directive (93/42/EEC) (MDD) and the Active Implantable Medical Devices...
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ARQon
Jun 28, 20191 min read
Get Ready EU IVDR: Factsheet & Step By Step Guide for Manufacturers of in vitro Diagnostic Medi
Background: The IVDR will replace the existing In Vitro Diagnostic Medical Devices Directive (98/79/EC) (IVDD). The transitional period...
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ARQon
Jun 28, 20191 min read
Europe - Jun 2019
Czech Republic: Form released for accessing online reimbursement system EU: Corrigenda published to Regulations 2017/745 and 2017/746 EU:...
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ARQon
Jun 28, 20191 min read
Drugs - Jun 2019
China - CFDA Announcement No. 2017/187: Announcement on Cancellation of Drug Protection Fees, Certification Fees, Import / Export...
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ARQon
Jun 28, 20191 min read
IVDR and Brexit Outlook for IVD Firms - Asian Medtech Associations Reg Networking
Executive Summary: This month's Asian Medtech Associations Regulatory Networking discussions is split into two parts, the first being a...
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ARQon
Jun 28, 20192 min read
EU MDR Designation of NB Updates
NB Listed in European Commission’s New Approach Notified and Designated Organisations (NANDO) To date, two Notified Bodies have been...
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ARQon
May 30, 20191 min read
EU MDR - Timeline Updates by European Commission
Transition Timelines from the Directives to the Regulations - Medical Devices and in vitro Diagnostic Medical Devices On 12 April, the...
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ARQon
Mar 29, 20191 min read
Europe - Mar 2019
EU: More advisory documents issued to support implementation of MDR and IVDR EU: Manual on borderline and classification issues updated...
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ARQon
Mar 29, 20191 min read
Drugs - Mar 2019
Australia - Procedure for Priority Review / Accelerated Approval China - NMPA Announcement 2019/10: Adjusting Classification of 12 Types...
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ARQon
Mar 29, 20192 min read
Connected Care in Europe – Report
Berg Insight analysed the latest developments on the telehealth and telecare markets in the Europe region. The study provides 165 pages...
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ARQon
Mar 28, 20192 min read
Australia TGA Plans for Brexit
The exit of the United Kingdom (UK) from the European Union (EU) will cause implications to the medical industry in Australia....
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