Medical devices to be marketed in the European market must obtain CE Marking as proof the devices meet the highest safety, health, and...

Denmark: New rules mean non-serious adverse events may also need to be reported EU: Application of Regulation (EU) 2017/745 postponed by...

Application of the Medical Devices Regulation (MDR) has been deferred by one year, until 26 May 2021, for fear of shortage or delay in...

There will be no transition period for Class I medical devices which remain in Class I under MDR. From 26th May 2020 onwards, the...

To comply with new MDR requirements in an efficient manner before the relevant international standard is available, MedTech Europe...

EU: Commission Implementing Decision (EU) 2019/1396 on the designation of expert panels EU: Industry expresses concerns about proposed...

It was confirmed by the European Commission on 30 October 2019 that the Medical Device Regulation (MDR) EUDAMED will be delayed for two...

Albania: Amendments proposed to ‘Law on Medical Devices’ EU: New MDCG documents on Notified Bodies, the person responsible for regulatory...

China : NMPA No. 2019/34 Issuance of Provision n Drug Quality Inspection and and Testing EU/US : EMA/FDA Analysis Shows High Degree of...

Background: The MDR will replace the existing Medical Devices Directive (93/42/EEC) (MDD) and the Active Implantable Medical Devices...

Background: The IVDR will replace the existing In Vitro Diagnostic Medical Devices Directive (98/79/EC) (IVDD). The transitional period...

Czech Republic: Form released for accessing online reimbursement system EU: Corrigenda published to Regulations 2017/745 and 2017/746 EU:...

China - CFDA Announcement No. 2017/187: Announcement on Cancellation of Drug Protection Fees, Certification Fees, Import / Export...

Executive Summary: This month's Asian Medtech Associations Regulatory Networking discussions is split into two parts, the first being a...

NB Listed in European Commission’s New Approach Notified and Designated Organisations (NANDO) To date, two Notified Bodies have been...

Transition Timelines from the Directives to the Regulations - Medical Devices and in vitro Diagnostic Medical Devices On 12 April, the...

EU: More advisory documents issued to support implementation of MDR and IVDR EU: Manual on borderline and classification issues updated...

Australia - Procedure for Priority Review / Accelerated Approval China - NMPA Announcement 2019/10: Adjusting Classification of 12 Types...

Berg Insight analysed the latest developments on the telehealth and telecare markets in the Europe region. The study provides 165 pages...

The exit of the United Kingdom (UK) from the European Union (EU) will cause implications to the medical industry in Australia....