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How will the new EU General Data Protection Regulation (GDPR) affect my clinical trial?

How will the new EU General Data Protection Regulation (GDPR) affect my clinical trial?


Getting ready for Europe’s new MDR - Clinical Evaluation

The European medical regulatory landscape is undergoing its most significant overhaul in years. The eagerly-awaited Medical Device Regulation (MDR), published in May 2017, will bring substantial changes to the way medical device manufacturers bring their devices into the European market. Download this white paper and discover nine important factors for the successful planning, development and maintenance of a Clinical Evaluation Report (CER).


UK to recognize CE Marks for limited time in case of ‘no deal’ Brexit

The UK’s Medicines & Healthcare products Regulatory Agency will continue to recognize CE Marked products for use in the country for a limited time following a ‘no deal’ Brexit scenario, according to new guidance from the agency.


Regulatory Affairs

Regulatory


Let's Get you Ready for your Clinical Trial | Webinar | EU perspective

Whether you are a first-time inventor or a large manufacturer, the thrill of bringing a medical device to market is both exhilarating and overwhelming. The development of a successful device not only requires optimized design efforts, but also clinical, regulatory & marketing expertise. Download this 30 min. webinar and increase your chances of successfully launching your medical device.


Israel expertise

Medical Device Manufacturers benefit from the partnership between genae and MedicSense as we now can provide pre- to post regulatory and quality expertise in addition to clinical trial management and digital health services. Download this info sheet and discover all facts & figures about our Israeli expertise.


Which medical devices fall under the EU MDR scope?

Which medical devices fall under the EU MDR scope?


By when do I need to update the Clinical Evaluation Report?

By when do I need to update the Clinical Evaluation Report?


MHRA Plans for the Future of Drug, Device Regulation Post-Brexit

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released today a business plan for the upcoming year, noting its primary focus on developing a consensus around a proposed model for the future of the country’s regulation of medicines and medical devices following its departure from the EU.


Final EU MDR, IVDR Texts Published

The final texts of the new European medical device and in vitro diagnostic (IVD) regulations were published today in the Official Journal of the European Union, setting in motion the timeline for implementation of the new regulations to commence on 25 May.