We have a customer who wants us to create one package that we they can use in both the U.S. and the EU. For the EU, one of the claims they want to make on the packaging is unsupported by our current test results so we said we can't put it on the packaging. They offered up an indemnity letter...
I am a manager with a company soon to go into liquidation. We have class IIb products on the market in Europe, the US and other markets world wide. What are the responsibilities for these products when/if the QMS ceases to function? does CE marking lapse immediately?
thanks for your help
Can someone explain to me - what are the obligatory timelines in EU for reporting incidents to authorities in case of active implant devices?
Is it similiar to class 1 and 2 devices?
2 days in case of public danger?
10 days in case of user death?
30 days for other mandatory...
In the MDD (93/42/EEC), there is "B" and M1 through M5" - what does that mean ? Also these alphabets have black triangles pointed either to right, or below or in between words.
What do all these mean ?
Here is the summary of updates that EU has included in new borderline manual (version 1.16)
1. Bedwetting alarm - intended for treatment of nocturnal enuresis (recognized as medical condition) medical device Class I
2. Riboflavin solution for treatment of keratoconus...
More than 7.2 billion people exist in the world today with half the global population residing in just six countries, United Nations data show.
I'm looking for some specific information regarding medical device registraion in Czech Republic::confused:
I know that if the Manufacturer is outside the European Union the notification to the Ministry of Health before should be done by the local Distributor; can someone confirm...
With regards to labelling an electrical medical device in the EU:
Obviously, the CE mark is required.
But what about the following:
- WEEE mark
- RoHS mark
- GS mark (for Germany?)
- Mark to show EN60601-1 compliance (such as the TUV T-mark)
Are the above marks:
- Required to be...
I am tasked to write a high level procedure on “Regulatory Compliance on Medical Devices” for my company at the Corporate level that would state we are in the field of medical devices and list various markets that we serve.
In line with the markets, I will also mention our device listings...
I am currently working on a lean transformation project in a distribution centre in Europe. They are in the process of implementing Lean and Operational Excellence (actually Lean has already been implemented, but they want to see more impact if they shift to Operational Excellence)...
I am having a little trouble navigating my way through the versions of standards that I need to comply with MDD 93/42/EEC.
En 60601-1 applies to my device. Amendment 1 of 60601-1 3rd edition quotes ISO 14971:2007 as a normative reference.
Which version, EN ISO 14971:2012 or ISO...
I'm implementing ISO 13485 in a small company. Regarding chapter 4.2.1(Documentation requirements - General), does anyone know which directives beside 93/42 EEC are applicable to a product that is a medical standalone software?