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Many people ask me these days: why the urgency with IVDs? The IVDR’s date of application (26 May 2022) is still almost two years away. Why the hurry? The hurry has everything…
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Last week we went past DoE (Date of Entry into force) of the MDR plus three years, and the date on which the MDR was supposed to have become applicable. As you,…
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Jasmin Buijs
What would food be without packaging? And what does packaging mostly consist of? Of course: plastic! To date, only few other materials have proved as reliable for food packaging as plastic. At the same time, we know that plastic has many disadvantages for the environment. Read this blogpost to be informed on the most important […]
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With the overwhelming vote in the Parliament in favor of the Commission proposal to amend the MDR it is politically basically a done deal now that the MDR will be amended. After…
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When it rains guidance, it pours. The MDCG just released Guidance on temporary extraordinary measures related to medical devices Notified Body audits during COVID-19 quarantine orders and travel restrictions. The guidance takes…
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It’s always a risk to put out a theory about legislative oversight after a Sherlock Homes investigation that eliminates all other options as I did in my last blog about the MDR…
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On Friday 3 April 2020 it finally happened: the Commission proposal for amendment of the MDR to defer the date of application with a year that everyone was waiting for and was in…
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After a statement on a press conference today by Stefan De keersmaecker that had many people very excited quickly, the official announcement came later in the afternoon: Here is what I think about…
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It’s hard to keep up with all the work and the new publications of guidance these days. Abundance creates its own problems one could say, so that’s why this blog was slightly…