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European Medical Device Regulation (MDR)

MedTech Europe has said it remains held back by “slow and piecemeal implementation” of the new IVDR and MDR framework. Read more

News

New EU rules for medical equipment will be introduced next year, but they won’t be enough to protect healthcare institutions against all cyber risks. Here are eight steps that lay the basis for strong cybersecurity. Read more

Features

Lee Stacey, product evangelist, Thingstream, writes about challenges faced by the medical device industry amidst the growth of IoT, and new European regulations that come into force next year. Read more

Features

The editors of Medical Plastics News and Med-Tech Innovation News want to know if you are ready for the enforcement of these regulations. Read more

News

With the fast approaching end of the EU MDR transition period (May 26th, 2020) manufacturers need to ensure their products meet the new requirements by the deadline or risk restricted EU market access. Read more

Features

Richard Poate, medical health services manager at global product testing and certification organisation TÜV SÜD writes about the effect of MDR. Read more

Features

The government state that the MDR will come in to effect in May 2020, and the IVDR in May 2022, however the United States has called upon the EU to delay the implementation of Medical Device Regulations and In Vitro Diagnostic Regulations by 3 years. Read more

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MedPharmPlast Europe welcomed more than 50 industry experts during a two-day event in Frankfurt. Read more

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The European Commission has revamped its medical device section on its website to include a portal that presents the new regulatory requirements targeted at impacted actors. Read more

News

Carl Mendonça, Ultrapolymers, outlines polymer choice considerations for successful plastics device components. Read more

Features

Brexit, the upcoming medical device regulation (MDR) and IVDR were among the topics discussed at the MedPharmPlast Europe (MPPE) conference in Brussels. Read more

News

A health sciences and regulatory company is expanding its services to the European Union’s medical device, pharmaceutical and manufacturing industries. Read more

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Melonie Warfel, vice president, medical device & diagnostics at Veeva Systems explains how companies can prepare for the new European medical device regulation. Read more

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RAPS and TOPRA have joined forces to deliver a workshop to help regulatory professionals understand the impact of the EU’s new MDR on combination products. Read more

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The labelling of medical devices can be a complex process. As EU MDR implementation heads closes, Mark Cusworth, Prisym ID asks - will your label comply? Read more

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With Brexit looming, Paul Brooks, executive director, Regulatory Affairs Professionals Society (RAPS) discusses how medical device companies should respond to the EU's new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Read more

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A global support programme to help medtech start-ups bring new devices to market faster has been announced by software vender MEDEI. Read more

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Albis Plastic is expanding its product portfolio to include custom compounds for healthcare applications, the company has announced. Read more

News

Dave Gray, editor of Med-Tech Innovation News, talks to some of the world-class speakers giving presentations during this year's Med-Tech Innovation Expo. Read more

Expo News

The honorary sponsor of MT-Connect has released new guidance and recommendations on medical device regulations (MDR). Read more

News