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...
top of page
Search
ARQon
- Jun 30, 2020
- 1 min
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...
100 views0 comments
ARQon
- Jan 31, 2020
- 1 min
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...
67 views0 comments
ARQon
- Jan 21, 2020
- 1 min
EU: Symbols Guidance for MDR
To comply with new MDR requirements in an efficient manner before the relevant international standard is available, MedTech Europe...
348 views0 comments
ARQon
- Dec 4, 2019
- 1 min
Europe - Nov/Dec 2019
EU: Commission Implementing Decision (EU) 2019/1396 on the designation of expert panels EU: Industry expresses concerns about proposed...
24 views0 comments
ARQon
- Nov 7, 2019
- 2 min
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...
114 views0 comments
ARQon
- Aug 30, 2019
- 1 min
Europe - Aug 2019
Albania: Amendments proposed to ‘Law on Medical Devices’ EU: New MDCG documents on Notified Bodies, the person responsible for regulatory...
50 views0 comments
ARQon
- Aug 30, 2019
- 1 min
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...
24 views0 comments
ARQon
- Jun 28, 2019
- 2 min
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...
181 views0 comments
ARQon
- Jun 28, 2019
- 1 min
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...
126 views0 comments
ARQon
- Jun 28, 2019
- 1 min
Europe - Jun 2019
Czech Republic: Form released for accessing online reimbursement system EU: Corrigenda published to Regulations 2017/745 and 2017/746 EU:...
23 views0 comments
ARQon
- Jun 28, 2019
- 1 min
Drugs - Jun 2019
China - CFDA Announcement No. 2017/187: Announcement on Cancellation of Drug Protection Fees, Certification Fees, Import / Export...
24 views0 comments
ARQon
- Jun 28, 2019
- 1 min
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...
12 views0 comments
ARQon
- Jun 28, 2019
- 2 min
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...
41 views0 comments
ARQon
- May 30, 2019
- 1 min
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...
861 views0 comments
ARQon
- Mar 29, 2019
- 1 min
Europe - Mar 2019
EU: More advisory documents issued to support implementation of MDR and IVDR EU: Manual on borderline and classification issues updated...
29 views0 comments
ARQon
- Mar 29, 2019
- 1 min
Drugs - Mar 2019
Australia - Procedure for Priority Review / Accelerated Approval China - NMPA Announcement 2019/10: Adjusting Classification of 12 Types...
21 views0 comments
ARQon
- Mar 29, 2019
- 2 min
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...
18 views0 comments
ARQon
- Mar 28, 2019
- 2 min
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....
49 views0 comments
ARQon
- Dec 18, 2018
- 2 min
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...
178 views0 comments
bottom of page