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India to import PPE from China in COVID-19 fight, says report
New reports say that India will stock up on personal protective equipment and ventilators by banning exports and importing from China.
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Medical Devices
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On the new EU MDR guidance for “significant change” and clinical evidence for software
Maurits Lugard, Josefine Sommer and Antoine Robin from Sidley Austin dissect the recently released EU guidance to accompany the MDR, on what a significant change is and how to collect clinical evidence for medical device software.
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FDA approves DURYSTA™ (bimatoprost implant) New Drug Application
The DURYSTA ocular implant has been approved by the FDA to reduce intraocular pressure in open-angle glaucoma or ocular hypertension.
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Emerade 150 micrograms auto-injectors recalled in UK
The UK MHRA has announced that Emerade 150 micrograms solution for injection is being recalled due to an error in one component of the auto-injector.
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PMP promotes success in India’s medical devices industry
According to renowned data and analytics company GlobalData, India’s phased manufacturing programme will create significant opportunities for medical device manufacturers in India.
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The role of ELSIE in evolving current thinking on extractables and leachables
Extractables and Leachables Safety Information Exchange (ELSIE) has been the most influential industry group in developing guidelines for extractables and leachables. In the wake of the ICH convening a new group to develop a concept paper and business plan on their Q3E Impurity Guideline, Dave Elder discusses the strides that…
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Medicines and Medical Devices Bill introduced in UK
A new bill is now effective in the UK which aims to improve regulation for medical devices and ensure patient safety, as well as allow hospitals to develop personalised medicines.
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Indian medical device manufacturers need support from multinational companies, says report
A report suggests that instead of taxing medical device imports, the Indian government should offer tax rebates to multinational companies if they partner with domestic device manufacturers.
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Safe’n’Spray™, the smart electronic concept device with child-resistant and locking features, wins the ‘Best Innovation In Drug Delivery Device’ Award at Pharmapack 2020
A team of industry experts awarded Nemera’s Safe’n’Spray with a prestigious Pharmapack Award for ‘Best Innovation in Drug Delivery Device’.
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4D-printed microneedles for drug delivery and biosensing
Researchers using 4D printing have developed microneedles with backwards-facing barbs that they suggest could replace hypodermic needles in prolonged drug delivery or biosensing in future.
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Medical Devices Regulation: delays and confusion
The EU Medical Devices Regulation will apply in May 2020. Maurits Lugard and Josefine Sommer of Sidley Austin LLP examine what the changes mean for the medtech industry.
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Brexit deal could negatively impact medical device development in UK, says report
New research suggests that a Brexit deal would obligate the UK to adhere to the EU MDR, imposing tighter restrictions on development and so hinder the industry.
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FDA approves first interactive digital inhaler sensor
The FDA has given its first approval to an interactive digital inhaler sensor that allows patients to manage their condition by providing instructions and recording usage data.
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EU MDR: best practices for bringing enterprise labelling under control
Faced with the looming deadline for compliance of May 2020, many medical device companies still haven’t fully grasped the impact of the new EU Medical Device Regulations (MDR) across all their product labelling. The requirements also affect what goes on Information-for-Use (IFU) leaflets and electronic equivalents. Here, Graham Francis offers…
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Medical devices: recent developments and the potential impact of Brexit
The current regulatory system for medical devices in the UK, as an EU member state, is complex enough without the uncertainties surrounding Brexit. In this article, legal advisor Paul Ranson reviews the current and forthcoming regimes and how Brexit may impact manufacturers and regulators working in this space.
