1. P

    IVDD - IFU related requirements - Type of information/statement expected

    Hi and welcome everyone first of all (been using the Cove for a while now, but this is my first post). I'm looking for some explanation what type of information/statement is expected to show compliance with the requirements listed in the Annex I, section B, clause 8.7: point 8.7 (j)...
  2. F

    Automated Platform (IVD) Classification/Registration (New to RA)

    Hi. I am new to the forum (first post) and actually relatively new to RA; only recently starting work as an RA specialist for a medical devices/IVD manufacturer (following a background in R&D). This may sound like a simple question but I'm really struggling to find an answer so am hoping...
  3. H

    ISO 14971 vs. IEC 62304 vs. 98/79/EC vs. ISO 13485 (Software Medical Device)

    Hi all I'm in a bit of a pickle and need your help. We made software which is classed as an IVD and are currently undergoing registration for ISO 13485 (2016), we also work to IEC 62304. For risk management we are working to ISO 14971, however there are clashes with the IVDD and by default need...
  4. O

    Design and Development Process - Does one size fit all?

    Hello Covers, I am tasked with updating our D&D process to better reflect all the different ways that we can do D&D activities. We currently have a "one size fits all" process, which is too robust for most of our activities. We manufacture IVDD tests. Some of these are for clinical, but...
  5. X

    Algeria IVDD Registration Requirements in English

    Could anyone help me on IVDD registration in Algeria? I could not read French, so I now only get a little information about it: Regulation of medical devices in Algeria is conducted by the Directorate of Pharmacy and by the National Laboratory for the Control of Pharmaceutical Products...
  6. A

    Confirming IVD exemption from WEEE

    Hello Cove Users, I have a question in relation to confirming IVD exemption to WEEE. The product I am trying to confirm exemption from WEEE is an instrument which is used in conjunction with IVD consumables for testing human serum/plasma samples. The product is general class according to...
  7. X

    Indian Medical Device Registration Requirements

    1. In IVDD FAQ, the 36 point shows: Whether devices imported under valid import license can stock in any other wholesale license premises other than stated in the Import License? Ans: Yes Does it mean that the devices with valid import license could be imported by other importers with...
  8. X

    Egypt In Vitro Diagnostics Medical Devices Registration

    Could anyone help me for the following questions on Egypt In Vitro Diagnostics Medical Devices Registration ? 1. I only found the Draft of Medical Device Regulations in EDA website, but it shall not apply to IVDD. Has this draft been effective? 2. Has the regulation for IVDD been issued...
  9. B

    Health Canada Acceptance Policy of Foreign Clinical Trial Data for Devices

    Does anyone know what Health Canada's policy is on accepting foreign clinical performance data for near patient Class III IVDD? I can't seem to find this in any guidance document. Any help would be very much appreciated.
  10. X

    In Vitro Diagnostic Medical Device in Palestine Registration and Importation

    Is it necessary to register the IVDD in Palestine, when import this product? Does anyone have experience on it? Thanks!
  11. X

    In Vitro Diagnostic Medical Device in Turkey Registration

    Does anyone have experience on In Vitro Diagnostic Medical Device in Turkey? Does Turkey have special directive for IVDD?, or only follow 98/79/EC? Thanks!
  12. L

    IVDD 98/79/EEC - Can I self declare?

    Hi Guys Looking for some help again :confused:. I have just received confirmation that a device we are looking at manufacturing will be covered as an IVD accessory. The item is inert and is designed not to touch the body and basically is a sample transporter to be used just prior to...
  13. P

    Proposed Changes to the Medical Device Directive (and IVDD)

    As I'm sure you are all aware the European Commission set out proposals for changes to the Medical Device Directive (and IVDD) in autumn 2012. (link) http://ec.europa.eu/health/medical-devices/documents/revision/index_en.htm In the UK our 'Competent Authority', the MHRA has been...
  14. M

    IVDD ER 8.3 Vs. Hazard Labelling Regulations - Which outranks?

    Hi All, A discussion has come up with our HS&E officer on the hazard labelling of products and information we need to show on primary, secondary and within the IFU. He, naturally, refers back to the CHiP and "new" CLP regulations and states that we must show the symbols, phrases, and then...
  15. wrodnigg

    New harmonised standards MDD and IVDD 2012/C 262

    By 2012-08-30 new list of the harmonised standards has been published: List of MDD harmonised standards LIst of IVDD harmonised standards Most interesting changes MDD are the harmonisation (changes) of the following standards: EN ISO 11137-2:2012 Sterilization of health care products -...
  16. D

    IVDD RoHS Directive Compliance to 2011/65/EU

    So, if I am making an IVDD I understand that I have until July 22, 2016 to get to compliance to the new RoHS directive. I asked my suppliers if they are compliant to the new directive, but they all insist that since there are no changes between the old (2002/95/EC) and new directive with respect...
  17. R

    No Stability Standard on latest List of Harmonized Standards IVDD

    When reviewing the recently published list of standards harmonized to the IVD directive the standard pertaining to stability testing of IVD reagents is no longer present (EN 13640:2002). http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2012:262:0029:0033:EN:PDF This makes sence as it...
  18. I

    IVDD - Software and Graphics Standards or Guidance Documents

    does anybody know of standards or guidance documents that I can use for and IVDD product and what symbols can be used with regards to graphics on the interface? thanks in advance
  19. M

    RoHs and Weee Requirements for a planned market launch in 2010

    For a general classification IVD complying with the 98/79/EC directive, what are the requirements for ROHS and WEEE for a planned market launch in 2010? I believe there is a ROHS exemption for IVDs through 2012 but I'm not sure if this applies for WEEE as well. Thanks.
  20. wrodnigg

    New Harmonized Standards MDD and IVDD

    Finally the 3rd edition of EN/IEC 60601-1 has been harmonized with the MDD. But they did not define any specific date, so EN 60601-1:2006 can be applied from now on (if there is an applicable part-2 standard) By OJ C 304 of 2008-11-27 two other new standards have been harmonized: EN...