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European Regulatory Roundup 2021: Extensive Reshaping Of Underlying Medical Device And IVD Structures

2021 witnessed a landmark event in May when the new Medical Device Regulation first applied. The medtech sector will experience a similar milestone this year with the new IVD Regulation coming into force in some four months' time. Medtech Insight reflects on the broad and complex swathe of changes that took place in 2021, putting industry under considerable pressure, and predicts no let-up this year.

EU Europe

Global Medtech Guidance Tracker: December 2021

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Fifty-eight documents have been posted on the tracker since its last update.

Guidance Documents Regulation

Turkish Health System Slides Into Crisis After Devaluation Of Lira

Amid delays in surgical operations caused by shortages of equipment and medtech companies demanding payment of outstanding hospital debts, a strong devaluation of the Turkish lira has put the local health care system on a crisis footing.

Turkey Policy

Global Medtech Guidance Tracker: November 2021

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-one documents have been posted on the tracker since its last update.

Guidance Documents Regulation

Global Medtech Guidance Tracker: October 2021

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-nine documents have been posted on the tracker since its last update.

Guidance Documents Regulation

US, UK, Canada Agree On Good Machine Learning Practices

The principals recommended by the three countries could be the foundation for how their regulatory bodies intend to regulate future AI/ML products.

Regulation Research & Development

Market Intel: Lessons Learned From COVID-19: A Global Perspective On Digital Health Transformation

Health leaders in Sweden, Norway, Australia, Canada and Taiwan predicted the universal impact of digital solutions during the pandemic and lessons learned that will impact future care.

Market Intelligence Coronavirus COVID-19

Global Medtech Guidance Tracker: September 2021

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.

Guidance Documents Regulation

Global Medtech Guidance Tracker: August 2021

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-nine documents have been posted on the tracker since its last update.

Guidance Documents Regulation

Global Medtech Guidance Tracker: July 2021

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-nine documents have been posted on the tracker since its last update.

Guidance Documents Regulation

Recall Of Sleep, Ventilator Devices Lead To International Patient Suits For Philips

Patients in Canada and the US are suing Philips over issues related to the company’s recent recall of CPAPs, BiPAPs, and mechanical ventilators.

Regulation Respiratory

MDR Makes EU ‘Much Less Attractive’ For Start-Ups, Says Medtronic EMEA Chief

The fragility of start-ups belies their value in medtech innovation, and they do not need unnecessary regulatory complications.

Europe Regulation
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