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Report: Most medical device makers not ready to meet E.U. MDR deadline

September 24, 2019 By Chris Newmarker Leave a Comment

Only about a fourth of medical device companies plan to be fully compliant with the European Union’s new Medical Device Regulation when it goes into effect on May 26, 2020, according to a new survey from the Regulatory Affairs Professionals Society (RAPS) and KPMG. The survey — which closed in late June and was released […]

Filed Under: Featured, News Well, Regulatory/Compliance Tagged With: EU MDR, European Union, KPMG, RAPS

Acorda’s Parkinson’s device moves closer to E.U. approval

July 26, 2019 By Nancy Crotti Leave a Comment

Acorda Therapeutics (NSDQ:ACOR) said today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of its Inbrija device for the intermittent treatment of  “off” episodes in people with Parkinson’s disease. The self-administered, inhaled therapy is designed for people experiencing a re-emergence of Parkinson’s symptoms. These “off” episodes are caused by low […]

Filed Under: Blog, Business/Financial News, Drug-Device Combinations, Featured, Regulatory/Compliance Tagged With: Acorda Therapeutics, European Medicines Agency (EMA), European Union

MedTech Europe warns of device flight to U.S. and China if MDR not ready

April 18, 2019 By Nancy Crotti Leave a Comment

Europe’s medical device trade group is again warning the European Commission that its new Medical Device Regulation (MDR) system will not be ready by its 2020 deadline and that E.U. medtech companies are taking their business elsewhere as a result. In an open letter to Jyrki Katainen, the commission’s vice president for jobs, growth, investment and competitiveness, […]

Filed Under: Business/Financial News, News Well, Regulatory/Compliance Tagged With: European Commission, European Union, MedTech Europe

7 medtech ideas out of Europe

October 9, 2018 By Chris Newmarker Leave a Comment

Mobile and digital health ideas — and overall medtech innovation ideas — abound in Europe, with DeviceTalks Boston attendees getting just a sampling this morning from seven CRAASH Barcelona participants. The CRAASH Barcelona program trains research projects on how to market their health technologies during a three- to five-year period. It’s a boot camp run by  EIT Health, the main European healthcare consortium, […]

Filed Under: Business/Financial News, Digital Health Tagged With: DeviceTalks Boston, Digital Health, European Union, spain, startups

Europe’s new MDR: Is it as scary as you might think?

March 2, 2018 By Chris Newmarker Leave a Comment

The European Union’s regulation of medical device appears to be increasing under the new Medical Device Regulation (MDR) going into effect, while U.S. FDA is easing off. In many ways, the E.U. and the U.S. are going in opposite directions when it comes to medical device regulation, said Michael Drues, a regulatory consultant based outside […]

Filed Under: 510(k), Business/Financial News, Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: European Union

Report slams European Union’s high-risk medical device approvals rate

January 2, 2018 By Heather Thompson Leave a Comment

A health economics and outcomes research group has concluded that the assessment for high-risk medical devices in the European Union is of low quality and needs improvement. The report appears in the December 2017 issue of Value in Health by ISPOR. Get the full story on our sister site Medical Design & Outsourcing. 

Filed Under: Business/Financial News, Regulatory/Compliance Tagged With: European Union

Why U.S. first may be the new medical device development strategy

June 6, 2017 By Chris Newmarker Leave a Comment

Increased regulatory hurdles in Europe and China could mean more medical device development focusing on the U.S. market first. That seemed to be a major takeaway from panels on regulation and reimbursement at Healthegy’s Medtech Conference, held last week in Minneapolis. “We’re actually going to be doing more early clinical work with the FDA,” said Stacey Pugh, vice […]

Filed Under: Business/Financial News, Food & Drug Administration (FDA), Regulatory/Compliance, Research & Development Tagged With: CE Mark, China, European Union, FDA, Fogarty Institute for Innovation, healthegy, Medtronic

E.U. publishes final version of medical device regulations

February 23, 2017 By Chris Newmarker Leave a Comment

Ronald Boumans, Emergo Final versions of the European Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) have been published, and will come to a formal vote by the European Council on March 7 and by the European Parliament on March 20. Following these votes, the MDR and IVDR are expected to be formally published in late […]

Filed Under: Regulatory/Compliance Tagged With: European Union, MedTech

Medical device companies fear parallel regulation after Brexit vote

June 30, 2016 By Fink Densford Leave a Comment

Medical Device companies fear that Britain’s exit from the European Union could result in a “parallel” regulatory system which would require them to file separate applications to access the U.K. and E.U markets, according to a new report from ScienceBusiness. Only 2 weeks ago, the Environment, Public Health and Food Safety Committee of the European Parliament […]

Filed Under: Regulatory/Compliance Tagged With: European Union

EN 60601-1 3rd Edition electrical standard now harmonized in Europe

June 4, 2014 By MassDevice Leave a Comment

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By Stewart Eisenhart, Emergo Group

Filed Under: Blog, News Well, Regulatory/Compliance Tagged With: Emergo Group, European Union

Judge cuts Biolase board of directors | Medtech legal news for the week of Mar. 31, 2014

March 31, 2014 By MassDevice staff Leave a Comment

UPDATE: Court cuts Biolase board, marketing VP under fire

March 24, 2014 by Arezu Sarvestani

Court halves Biolase board, marketing VP under fire

Filed Under: Legal News, News Well Tagged With: Alliant Enterprises, Biolase, Corporate Action Network, Ethicon, European Commission, European Union, Intuitive Surgical, Johnson and Johnson, Legal Roundup, Millennium Dental Technologies, Oracle Partners, Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), Stryker, U.S. Justice Dept. (DOJ)

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