Category - Recast

medicaldeviceslegal

Standardisation request for MDR and IVDR refused – now what?

A new blog post, a new step in the soap that is the non-transitional period of the MDR and the IVDR. I have jokingly paraphrased the absurdist painter Magritte by saying “céci n’est pas une période de transition”. I’m contemplating starting a T-shirts business with memes for the MDR and IVDR, with that meme and […]

medicaldeviceslegal

The urgency with IVDs and the IVDR

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 to do with simply counting back from the date of application and understanding the requirements of the IVDR. Notified bodies are very scarce […]

medicaldeviceslegal

The urgency with IVDs and the IVDR

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 to do with simply counting back from the date of application and understanding the requirements of the IVDR. Notified bodies are very scarce […]

medicaldeviceslegal

MDR date of application move: politically a done deal now

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 the vote there were people that immediately stated that the amendment was formally approved – not so. We are looking at law making […]

medicaldeviceslegal

New MDCG guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions

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 immediate effect and is valid for the whole period of duration of the pandemic COVID-19 as declared by the World Health Organisation. It […]

medicaldeviceslegal

The MDR amendment proposal: more than meets the eye

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 the works for some time was finally published. As I have heard from many directions immediately after the announcement of the proposal being […]