Informational UK – Brexit operational readiness guidance for the health and care system in England

#2
Hello Marcelo, long time no see! I hope you're doing well.

We're in a mess in the UK and EU, regardless of Brexit.

We have too much misinformation spilling form the top and most people just go with the flow.

I was at MedTech UK 2018 where our CA was promoting contact lenses as cosmetics.
I queried it and was told I was incorrect even though there had already been a court ruling in the European Court of Justice to clarify this for the CAs.

At IRIC May 2018 our CA was promoting blood and blood products as medical devices!

When NBs were under performing, the EC published a recommendation for NBs.
NBs and Team NB told industry these were all new requirements, when most had existed since 1993.

I wrote to Team NB and queried this. They insisted the recommendation was a new requirement!

I recently had a new 'EU Medical Devices Expert' tell me to put a WARNING on a device rather than a CAUTION.
I explained to her the difference, but she would not accept it.
She said 'there is no definition for WARNING?CAUTION and they are exactly the same.

I responded with FDA definitions, 60601 etc but this 'Expert' was a newly qualified medical doctor and she refused to accept my knowledge and 19 years experience.

So we're in trouble here and nobody is listening. Not even the CAs years ago when I warned them we would have a situation like we have today with toxic implants.
 

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