All Medical devices articles – Page 2
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JournalIMDRF: Origins, purpose and current work
In a landscape of rapidly evolving technologies, the International Medical Device Regulatory Forum (IMDRF) aims to accelerate international medical device harmonisation. A summary of the work being undertaken by the IMDRF.
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Case StudyUnderstanding key components of a clinical evaluation
Written by Angela Siebeneck, Director of Regulatory Strategy and Policy from Certara based on an online seminar presentation, made in collaboration with TOPRA and Certera, given on 15 November 2022.
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JournalIVDs and medical devices — post-market surveillance and clinical follow-up requirements
Written by Kirsten Van Garsse from Qarad (part of the QbD Group) based on an online seminar presentation, made in collaboration with TOPRA and QbD, given on 6 December 2022 by Kirsten Van Garsse and Anne-Sophie Grell from QbD.
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Meeting ReportMD2: How to approach Artificial Intelligence
and Cybersecurity now and in the futureCybersecurity is important for medical devices – those designed before the era of cybersecurity are most vulnerable to malware attacks and industry are searching for solutions.
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![[FROM LEFT] Alwin van den Broek and Walter van Der Weegan](https://ds982gbwnvyso.cloudfront.net/Pictures/100x67/4/3/0/430_5m4a4635_toprasymposium2022_day3_20221019_77249.jpg)
Meeting ReportMD3: Clinical investigation from
a virtual setting perspectiveThere is a variety of devices currently used to collect PROs and the data gathered in relation to orthopaedic surgery. The forthcoming AI, cyber resilience, data governance, and digital market acts are proposed as the regulatory landscape of the future.
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Meeting ReportMD4: Challenges and opportunities for
small companies and start-upsWhen developing novel products, small companies and start-ups must understand the regulatory pathways to market. NBs are providing support to industry in its transition to the EU Medical Device Regulation, but NBs are in high demand.
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Meeting ReportMD5: How to maintain your medical device
on the market and fulfil ongoing obligations
in the post-launch phaseEUDAMED is an integral part of the MDR and the actors, UDI and certificate modules are now live. The full effect of EUDAMED will not be realised until it is fully functional – all actors should accelerate their preparation for EUDAMED and upload information as soon as modules go live.
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JournalNavigating the MDR’s heightened surveillance and performance requirements
Substantial changes to post-market surveillance, post-market clinical follow-up and the new requirement to include a summary of safety and clinical performance, have all placed greater obligations on medical device manufacturers. The changes introduced by the Medical Device Regulation (MDR), have the overarching objective of improving patient safety and providing greater ...
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JournalOne year experience on EU Medical Devices Regulation (MDR) 2017/745 for single integral drug-device combination products
Since 26 May 2021, Article 117 of the MDR asks for a notified body opinion (NBOp) to be included in the marketing authorisation applications (MAAs) for medicinal products that are a single integral drug-device combination.
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JournalMedical device standards update: February 2022
This edition of our regular column updates the progress of applicable horizontal standards to February 2022
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JournalThe national competent authorities of Belgium and Luxembourg share their views about the e-PIL Pilot
Q: Why do the authorities support the e-PIL Pilot and why do you think it is important? A: Iris Geussens: Digitalisation is the future, and the pharmaceutical sector cannot stay behind. The advantage of an electronic package leaflet is that you always have access ...
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JournalPlanning for the future: sustainable medical devices
Pharmaceutical and medical device companies are increasingly looking at new ways to incorporate sustainability into their strategies in a bid to help the environment. While existing medical device standards do not address sustainability explicitly, ISO working groups and others are now considering sustainability as an important component of medical device development. The heavily regulated world of medical devices will likely see sustainability standards emerging in the next decade.
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JournalElectronic leaflet pilot in Belgium and Luxembourg hospitals
The e-PIL Pilot was set-up in Belgium and Luxembourg with the objective to demonstrate the equivalence between the paper patient information leaflet and the electronic patient information leaflet in providing information on the safe and effective use of medicines in hospital setting. The first results of the Pilot are promising ...
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JournalSubstance-based medical devices: regulatory challenges and prospects
Substance-based medical devices comprise a diverse group of products that are regulated under the Medical Devices Regulation, which is applicable since 26 May 2021. Compared with the previous legal framework, the MDR has introduced several extensive changes to the regulatory framework for medical devices that also impact on the marketing of substance-based medical devices in the EU…
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Meeting ReportMD4: Clinical investigations – Is coordinated CA assessment the future?
The first speaker was Amy Bennet, who highlighted that any coordinated clinical assessment requires sound data gathered from preclinical development, especially in class IIa, IIb and above devices.
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Meeting ReportMD2: Global development strategy, which market should you go to first?
Michelle Lotte started the session. She summarised considerations of the MDD/MDR transition against submission to the FDA.
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JournalEU PIP breast implant withdrawal
The Poly Implant Prothèse (PIP) silicone breast implant failures had a socioeconomic impact at an international level, affecting nearly 400,000 patients in 55 different countries,[1] and resulted in major EU regulatory updates. PIP was a French company founded in 1991 and it produced approximately two million sets of silicone breast ...
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JournalFundamentals of the European devices regulatory framework
In the EU, the development of medical devices is supported by the European Commission Directive (93/42/EEC Medical Devices Directive). To this, the EU has a unique system in dealing with medical devices, iconised as the CE Marking, which provides the right for the products to be commercialised in the EU. This continuing professional development supplement presents the unique system of medical devices that is currently applied in the EU. Additionally, the new regulation of medical devices (EU 2017/745 Medical Device Regulation) is also covered.
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JournalEluvia: a drug-eluting stent
Peripheral arterial disease (PAD) affects around 8–12 million people in the US.[1] The strong association with ageing, tobacco smoking, and diabetes means that the prevalence of PAD will continue to increase in the coming years. Although 20–50% of patients with PAD are asymptomatic, they are still at significant risk of ...
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JournalFDA regulatory pathways for medical devices
The regulations, developed as a result of the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1938, share a common goal with the pharmaceutical regulations: they both strive to ensure that new medical treatments reach the public as quickly as possible while protecting patients and ensuring that the new treatments have a positive benefit–risk balance. However, they approach this goal in different ways. This continuing professional development supplement explains the fundamentals of the FDA regulatory pathways for medical device manufacturers that wish to bring their products to the US market.
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