News
US AAMI adopts ISO14155
The US Association for the Adavancement of Medical Instrumentation has adopted the revised international standard ISO 14155 on medical device clinical investigations. Read More...
August 01 2011
The Global Harmonization Task Force guidance on reporting AEs during pre-market clinical investigations
The Global Harmonization Task Force have produced new guidance on reporting adverse events during pre-market clinical investigations of medical devices and is seeking stakeholder feedback. Comments will be accepted until 10 December this year. Read More...
August 01 2011
Medvance continues to expand
Medvance are pleased to announce that our UK based clinical research team has again been expanded. Read More...
August 01 2011
Medvance Launches ISO14155 e-learning Course
Medvance have launched a new easy to use e-learning training course on the latest version of ISO 14155. Read More...
July 29 2011
Borderline and Classification in the community Regulatory Framework for Medical Devices
Borderline cases are considered to be those cases where it is not clear from the outset whether a given product is a medical device, an in vitro diagnostic medical device, an active implantable medical device or not. Or alternatively, borderline cases are those cases where the product falls within the definition of a medical device but is excluded from the directives by their scope. Where a given product does not fall within the definition of medical device or is excluded by the scope of the directives, other community and/or national legislation may be applicable. Read More...
April 05 2011
European Commission considers single submissions for multi-site investigations
The details of how the commission is envisaging managing multi-site clinical investigation applications for medical devices under the recast medical device directives are set out in a so-called "non-paper" from the commission that Regulatory Affairs Medtech sister publication Clinica Medtech Intelligence has obtained. Read More...
March 31 2011
ISO 14155 2011 Major Changes – SAFETY
The revised standard ISO14155 - has a new title - Clinical Investigation of Medical Deices for human subjects - Good Clinical Practise. This reflects its closer relationship with international good clinical practise regulations and guidelines. Manufacturers should be aware of these changes, one of the main changes is around safety evaluation and reporting. Read More...
March 31 2011
The MHRA Are Moving
As of 25th October 2010 the MHRA will be moving from their home in Vauxhall to their new address in Victoria: Read More...
October 22 2010
Important Updates to SAE Reporting in Europe
Directive 2007/47/EC came into force on 21st March 2010, amending the Medical Device Directive 93/42/EEC and the Vitro Diagnostic Directive 98/79/EC. One of the changes concerns serious adverse event (SAE) reporting, whereby all SAE's now need to be reported to all Competent Authorities where a clinical investigation is taking place. Read More...
June 10 2010
EUDAMED Database
A new amending directive, 2007/47/EC, came into force on 21st March 2010, which amends the Medical Device Directive, 93/42/EEC. A new article has been added, Article 14a covering the requirements for a new European Database. Read More...
April 27 2010
Kath Clarke joins Medvance team as Regulatory Affairs Manager
Medvance are delighted to announce that Kath Clarke has joined the ever expanding Medvance team based in Burn, near Selby in the UK. Read More...
April 07 2010
Update to the Medical Device Directive - How does it affect you?
The fifth amendment to the Medical Device Directive (2007/47/EC) went live on 21Mar10, amending the MDD (93/42/EEC) and AIMDD (90/385/EEC). Many of the changes were ‘housekeeping’ and minor changes however, several of the more major amendments could have serious impact on you and your company. Read More...
April 07 2010
Management and use of IVD point of care test devices -DB2010(02)
The MHRA has revised their advice and guidance on the management and use of point of care testing (POCT) in vitro diagnostic (IVD) devices. They provided a guidance document in 2002 and this is the first time it has been revised. Read More...
April 07 2010
The First Dedicated Recruitment Website for Professionals in the Medical Devices Industry
Medvance Resourcing specialises in recruitment for the medical device industry, combining recruitment expertise with industry knowledge to offer a unique service to both clients and candidates. Read More...
April 22 2009