Do medical devices being exported from the US to Bonaire need to follow the same regulatory requirements as if they were going to the Netherlands?
From my research, the Netherlands require an authorized representative to register a medical device with their regulatory authority and IFU must...
I came across a strange event last year.
Our site in France was preparing for the ISO 9001:2008 certification.
To support the site they had make use of a ISO person who helped them with their compliance towards ISO 9001.
Due to some changes in the quality control...
I would be grateful if someone could provide with the requirements for first marketing of a CE marked medical device in the following EU countries:
- United Kingdom
I know that such a "declaration" is required in France, Italy or...
We have plan to launch our medical product in EU, and our Authorized representative is in Netherlands.
I heard that we must submit Technical files to EEA authorities, but I don't know which ministry we submit to.
Which ministry we submit to?
MHRA isn't it?
Does an IVD production company, that resides in one of the EU-member state, have to have a local authorised representatives in other EU-countries it sells its IVDs?
Example: our IVD company is located in the Netherlands. Do we have to have a German local authorised representative in Germany if...
In a hospital pharmacy in the Netherlands we produce certain drugs in small lots consisting of about 20 units (bottles). For the analysis of the content of the active substance we are exploring possibilities to use statistical methods for the sampling and analysis. The problem is that the...
I wonder if anyone can help. I have a Class III Medical Device for which I have just obtained a CE mark for. For it to be used in each of the member state countries do I need to complete any notifications/registrations?
I urgently in particular need to know about the Netherlands.
My dearest Cove friends,
My management has given me a new focus for this year, being Risk management according to ISO 14971. My first quest for a decent course has not delivered the desired result yet.
Does anybody know of an initial training on this specific subject in or around the low...