europe

  1. supadrai

    Indemnity Letters - What's the Deal?

    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...
  2. S

    Status products when/if the QMS ceases to function?

    Hello, 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
  3. rob73

    EU Medical Device Classification Spreadsheet

    Would someone like to break my classification spreadsheet? I've had a go but so far is works! If anyone is interested I'll post the unprotected version.
  4. M

    EN Standard (ETSI EN 301 489-3 v1.6.1) is Harmonized but not on Europa List

    The ETSI EN 301 489-3 v1.6.1 standard claims to be harmonized, but I can't seem to find any reference to it on the Europa list of harmonized standards. I must be missing something here...
  5. T

    Training courses for improving 'Coaching and Mentoring skills' within Europe

    Hi, Can anyone suggest some good training courses for improving 'Coaching and mentoring skills' within Europe? :applause:
  6. A

    What are the obligatory medical device reporting timelines for AIMD devices ?

    Dear all, 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...
  7. S

    Is Combination Product regulation available for Europe?

    Similar to 21 CFR Part 4 (Combination Products) in the US, does EU have a similar concept ?
  8. S

    What does B, M1 through M5 and the black triangle mean in MDD ?

    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 ?
  9. R

    EU updated borderline manual - version 1.16

    Hi all, 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...
  10. Ajit Basrur

    Six countries that make up half the world?s population

    http://blogs.marketwatch.com/themargin/2014/07/14/six-countries-that-make-up-half-the-worlds-population/?mod=MW_home_latest_news 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. China and...
  11. M

    Medical Device Registration in Czech Republic

    Dear all, 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...
  12. M

    Compliance Marks on Labeling - Required, recommended, or useless?

    Hi Everyone, 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...
  13. S

    Does anyone have procedure on "Regulatory Compliance"?

    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...
  14. J

    Lean Transformation Project - Distribution centre in Europe

    Hi All, 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)...
  15. S

    Identifying gaps over ISO 13485 to be compliant to MDD 93/42/EEC requirements

    We have a location certified to ISO 13485 and would like to find gaps over 93/42/EEC requirements - does any one have ready reference. Pls help :thanks:
  16. S

    Medical Device Product Recall per EU Requirements

    Friends, can some one urgently share me the procedure on "Product Recall" for medical devices per the European Union requirements ?
  17. I

    Quality and Operational Excellence Training Institutes in Europe

    Hi everyone :bigwave: Can someone recommend me some training institutes in Europe who deliver courses about quality, operational excellence...? Many thanks,
  18. M

    MDD Europe: Use EN ISO 14971:2012 or ISO 14971:2007

    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...
  19. S

    What are export requirements for Class I/II Medical Devices in Europe?

    Hi, Europe - Class Is/ II Medical device Export requirements. Please guide me on this. Thank you Sherley
  20. N

    Which regulations apply to Medical Stand Alone Software in Europe?

    Hello all! 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? Kind regards
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