David Wallace
Deputy Editor
Deputy Editor
Ireland
+10 year(s) experience
Medtech Insight: 世界の医療機器・医療技術の最新情報
There may have been a significant increase in the amount of regulatory activity at EU level of late, but the medtech industry remains alarmed at the lack of readiness of the system, and calls for an urgent focus on IVDs now too.
Medtech Insight: 世界の医療機器・医療技術の最新情報
The recent no-deal Brexit notice from the UK government says that companies selling devices in the UK would need a "Responsible Person" in the UK if the firm is not based there. The government clarifies to Medtech Insight that such person must be physically present in the UK, and not simply have an address there.
Topic brexit
Medtech Insight: 世界の医療機器・医療技術の最新情報
The UK government is introducing new registration requirements for medical devices in the event of a no-deal Brexit. They will be rolled out according to the risk class of products. But some fundamental questions have arisen.
Medtech Insight: 世界の医療機器・医療技術の最新情報
There had been warnings that the first notified bodies would not be designated by the European Commission until late July 2019, 10 months before the full application of the EU Medical Device Regulation. But now that BSI is the first notified body in the EU to be designated under the MDR, are things looking up?
Topic medtech
Medtech Insight: 世界の医療機器・医療技術の最新情報
Efforts are underway by EU notified body groups to encourage a uniform interpretation of the EU MDR when it comes to the risk classification of spinal implants. Their work could also reduce the amount of unnecessary notified body and expert panel work on some implantable devices.
Topic medtech
Medtech Insight: 世界の医療機器・医療技術の最新情報
With a growing urgency for medtech manufacturers to take decisive action so their products are not banned from the market under an increasingly likely no-deal Brexit, clients of BSI will be relieved to hear their notified body believes time is on their side.
Topic medtech
Medtech Insight: 世界の医療機器・医療技術の最新情報
Belgium is introducing new registration requirements for medical device and IVD operators June 17, ahead of the full application of the EU's medtech regulations and new Eudamed medical device database.
Topic business-strategies
Medtech Insight: 世界の医療機器・医療技術の最新情報
The new EU Medical Device Regulation offers companies an option to market CE-marked devices for an extra four years under current directives. But more hurdles are being identified that make this option less attractive.
Topic Brexit Business strategies
Medtech Insight: 世界の医療機器・医療技術の最新情報
UK starts to discuss emergency measures around devices as no-deal Brexit concerns mount. But it is still looking like the UK will continue to implement the Medical Device Regulation, in the short-term at least. Will it be a different matter for the IVD Regulation?
Medtech Insight: 世界の医療機器・医療技術の最新情報
The EU body that will drive implementation of the new Medical Device and IVD Regulations
Medtech Insight: 世界の医療機器・医療技術の最新情報
The EU Roadmap has been published. But it represents a dawning of a hard truth.
Medtech Insight: 世界の医療機器・医療技術の最新情報
While UK medtech is absorbed by uncertainties caused by Brexit and the new EU regulations, it is being eyed by the US, which sees opportunities.
Topic Brexit
Medtech Insight: 世界の医療機器・医療技術の最新情報
If there is a delay in appointing EU notified bodies under the new Medical Device and IVD Regulations.
Medtech Insight: 世界の医療機器・医療技術の最新情報
How can you be sure that your notified body is operating fairly and to a high standard? How long can your products remain on the market if your notified body’s operations are suspended or simply cease? Chapter IV of the forthcoming Medical Device and IVD Regulations details requirements for notified bodies as well as the process for their designation and monitoring.
Medtech Insight: 世界の医療機器・医療技術の最新情報
2017 is going to be a pivotal year for EU medtech regulations. We are expecting the new Medical Devices Regulation and IVD Regulation to take effect. But there are some big concerns and uncertainties at the center of it all.
Topic Policy and regulation Medtech
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