Medical devices: EU regulations for MDR and IVDR

Europe – Medical devices: EU regulations for MDR and IVDR

Overview This guidance provides information on the new EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR). Medical device types and their...
KPMG and RAPS: Medical Device Companies Under-prepared for European MDR

Europe – KPMG and RAPS: Medical Device Companies Under-prepared for European MDR

EMERGO SUMMARY OF KEY POINTS: A new medical device industry survey finds many firms still lack a firm understanding of the European Medical Devices...
Notify MHRA about a clinical investigation for a medical device

UK – Notify MHRA about a clinical investigation for a medical device

Contents Christmas period 2018 How to notify MHRA of your clinical investigation In Vitro Diagnostic Medical Devices (IVDs) Special circumstances for healthcare establishments Heath...
Roche CoaguChek device producing inaccurate results

UK – Roche CoaguChek device producing inaccurate results

People on blood thinners who use the CoaguChek device to test their blood clotting function are being urged to check their test strips, following...
The EDQM has issued a set of recommendations for the development of cost-effective and sustainable Quality Management Systems (QMSs) in Blood Establishments (BEs) across Europe.

Europe – The EDQM has issued a set of recommendations for the development of...

The EDQM has issued a set of recommendations for the development of cost-effective and sustainable Quality Management Systems (QMSs) in Blood Establishments (BEs) across...
TÜV SÜD Survey: Expected Shortage of Notified Bodies Under EU MDR/IVDR

Europe – TÜV SÜD Survey: Expected Shortage of Notified Bodies Under EU MDR/IVDR

Findings from a recent survey of notified bodies (NB) in Europe suggests the audits needed for compliance with the new medical device regulation (MDR)...
Digital health projects win £17 million

Europe – Digital health projects win £17 million

Satalia, working with Great Ormond Street Hospital, London, intends to use artificial intelligence (AI) to schedule operating theatre use linked to downstream bed availability...
Effects of “No Deal” Brexit for Medical Device Sector

Europe – Effects of “No Deal” Brexit for Medical Device Sector

EMERGO SUMMARY OF KEY POINTS: A “no deal” or “Cliff Edge” Brexit is a realistic scenario, becoming more realistic every day. The UK government...
Notify MHRA about a clinical investigation for a medical device

UK – Notify MHRA about a clinical investigation for a medical device

You may need to carry out a clinical investigation as part of the process to obtain a CE marking for your medical device. You...
Are You Really Ready For MDR?

Europe – Are You Really Ready For MDR?

Audrey Turley doesn’t shy away from speaking about biocompatibility topics related to medical devices. Turley serves as a senior biocompatibility expert for Nelson Labs....

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