Eucomed

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More white smoke – trilogue for MDR and IVDR in progress

White smoke again! After a long summer following the partial general approach on 19 June in which there was not much to report the Council now reached a general approach on the…

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Netherlands medical devices compliance update

Last week I attended the Eucomed Compliance Committee meeting in Brussels, and presented on some of the compliance developments going on in the Netherlands with respect to medical devices. Just like all…

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Update on Commission reaction to ENVI resolution – no PMA proposal on the table

In my previous post on this topic I wrote that it looked like the Commission had changed tack to propose a pre-market authorisation (PMA) for medical devices after all. It turns out that…

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It's official: the ENVI resolution is out in final version – EU Commission changes tack to propose PMA for devices

Some time ago I wrote about the proposed ENVI resolution that the the EU Parliament’s ENVI committee adopted in reaction to the PIP breast implants scandal in the EU. At that time…

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EU ENVI Parliamentary Committee resolution re Review : "learn the lessons of this fraud" and an FDA internal report

The European Parliament’s ENVI Committee (Committee on the Environment, Public Health and Food Safety) has added to the political pressure on the European Commission that is currently working on the proposal of…

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Developments and outlook re anti-kickback and corruption in the Dutch devices sector

Although no significant things happened in business compliance developments on a EU level for some time since Eucomed asked itself about guidance for sponsorship of conferences, things are very much in flux…

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Something new at Eucomed's MedTech Forum (also about the Recast)

Right after the event I wrote about in my previous post I visited the Eucomed MedTech conference in Brussels on 12-14 October 2011. At the end of conference I did learn something…

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Eucomed Compliance Panel speaks out on sponsorship of medical conferences

Many medical devices companies have invested in making their marketing actvities aimed at healthcare professionals Eucomed Code of Ethical Business Practices compliant. Although the Eucomed code has a lot of authority in…

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