RSS

Regulation

The European Commission has published the in vitro diagnostic medical device Regulation (IVDR) and the medical device Regulation (MDR) more

5 May 2017 15:25 News

European events cover regulatory affairs in the medical device sector more

12 Apr 2017 11:08 News

With MasterControl, Megadyne confidently demonstrates to regulatory bodies throughout the world how it complies with record retention, documentation and change control. more

26 Jan 2017 08:43 News

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. more

19 Jan 2017 14:15 News

IDC’s MD, Stephen Knowles, advises about the regulatory requirements for connected medical devices. more

14 Dec 2016 09:00 News

Maetrics reveals how to navigate post-market surveillance requirements in free whitepaper more

11 Apr 2016 14:37 News

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 more

16 Mar 2016 10:14 News

The latest edition of ISO 13485, the quality management systems standard for the medical device industry, has been published more

29 Feb 2016 10:49 News

European Union regulations that date back to the 1900’s are currently under reform. more

24 Jun 2015 12:17 News

Shedding light: Brett Rowland and Magdalena Gray, Eversheds LLP, outline the changes to the law on medical devices in the EU and what this will mean for manufacturers. more

3 Nov 2014 12:13 , News

Talking point: Mark Hassenplug, president and ceo of global life sciences compliance consulting firm, Maetrics, was selected to give a keynote address on the medical device industry and the changing global regulatory landscape it faces. more

9 Jun 2014 22:25 News

Bill Carteaux640X480.jpg

Source: Messe Düsseldorf.

Bill Carteaux, President and CEO of SPI: The Plastics Industry Trade Association—based in Washington, DC, USA—writes about how the association provides legislative and regulatory advocacy on behalf of the plastics industry. more

2 Jan 2014 13:55 Opinion

Leaders of the chemicals industry are travelling to London today for a summit chaired by Cabinet Minister Ken Clarke to discuss the proposed free trade agreement between the EU and the US. more

18 Nov 2013 16:19 News

MasterControl, a USA-based provider of quality management software solutions, has announced the establishment of a partnership with the globally respected International Quality Consulting (IQC) Group. more

14 Nov 2013 14:05 Technology

Eucomed welcomes the results of a plenary session which has endorsed essential measures that strengthen patient safety and which has improved the approaches on the approval system. But questions remain on re-processing of medical devices. more

23 Oct 2013 09:38 News

RoHS sets out limits for hazardous substances like lead and mercury in electric and electronic devices. In July 2014, medical devices will be subject to these limits. And in July 2016, all in vitro diagnostic medical devices must be compliant. more

8 Oct 2013 11:46 Opinion

Eucomed has voiced strong concern over a new scrutiny procedure, which it says will hamper innovation while resulting in patients waiting longer for life saving medical technologies without improving safety. more

1 Oct 2013 00:00 News

The EU Parliament has voted in favour of reforms to the CE marking procedure for medical devices. Eucomed has severely criticised the move saying it "brings unnecessarily delays in lifesaving medical technology". more

25 Sep 2013 19:24 News

Ahead of a European Parliament vote on the proposed medical devices approval process, Europe's medical device industry association has provided a clear warning that the system would put patients, SMEs and jobs at great risk. more

12 Sep 2013 10:26 News

Test data and regulatory documentation for medical device submissions to the FDA. more

3 Sep 2013 10:08 Technology