Regulation
UK to mirror MDR and IVDR in event of no deal Brexit
The MHRA has reiterated guidance on how medical devices will be regulated in the event of a no deal Brexit. Read more
Regulation and Brexit among topics covered at MPPE event
MedPharmPlast Europe welcomed more than 50 industry experts during a two-day event in Frankfurt. Read more
European conference launched by the Regulatory Affairs Professionals Society
The new Europe-based conference plans to build on The Regulatory Affairs Professionals Society’s (RAPS) track record of successful events at a time where there are many changes within the European regulatory environment. Read more
Around 400 exhibitors expected at MedtecLive
The entire medical technology value chain will be represented at the Exhibition Centre Nuremberg for the international MedtecLive exhibition and the MedTech Summit Congress from 21-23 May. Read more
Why manufacturers need a clear roadmap for compliant clinical evaluation reports
Manufacturers need to set a clear roadmap to compliant clinical evaluation reports, says David Egbosimba, solutions delivery manager, Maetrics. Read more
Medical device regulation 'not fit for purpose', MP states
A historical lack of transparency in the UK’s medical devices industry has led to debilitating consequences for patients, the government admitted this week. Read more
A little more accessible: What's to come in the year ahead
Group Editor Dave Gray shares his predictions for 2019 on how regulation and technology will affect the industry. Read more
Seeking approval: The challenges start-ups face gaining medical device approval
Maik Endler, Knoell Germany, examines the challenges for start-ups gaining medical device approval. Read more
New talent needed for a new era of market access in the medtech industry
Paul Bulteel, partner at life sciences executive search firm the RSA Group, discusses why the medtech industry needs new talent to help navigate regulatory changes and enable market access for medical devices. Read more
Why Brexit, regulations and investment are vital for UK medtech
Exhibitors attending the Med-Tech Innovation Expo share their views on Brexit, sector expectations, key initiatives and more in this insightful interview into the medtech industry. Read more
New FDA guidance aims to aid medical device development
The FDA has released new guidelines to aid medical device regulation and assess the effectiveness of cardiovascular products. Read more
Ready, steady, go: Tightened EU medical device regulations are here
The European Commission has published the in vitro diagnostic medical device Regulation (IVDR) and the medical device Regulation (MDR) Read more
Events examine EU regulations and directives
European events cover regulatory affairs in the medical device sector Read more
Consolidation helps Megadyne successfully comply with multiple regulatory agencies
With MasterControl, Megadyne confidently demonstrates to regulatory bodies throughout the world how it complies with record retention, documentation and change control. Read more
Medical devices regulations to be adopted by Europe in May
Two proposed regulations on medical devices and in vitro diagnostic medical devices (IVDs) will be adopted by the European Commission by the end of May. Read more
Playing by the rules: Regulatory requirements for connected medical devices
IDC’s MD, Stephen Knowles, advises about the regulatory requirements for connected medical devices. Read more
Medical device industry braced for spotlight on post-market surveillance
Maetrics reveals how to navigate post-market surveillance requirements in free whitepaper Read more
Regulators crack down on medical device sector
Regulators are heightening post-market surveillance requirements to ensure medical device safety issues are identified as early as possible. Maetrics has written a whitepaper on how to navigate these requirements Read more
New standards for medical device quality management
The latest edition of ISO 13485, the quality management systems standard for the medical device industry, has been published Read more
New framework for European medical device regulations
European Union regulations that date back to the 1900’s are currently under reform. Read more