ivd (in vitro diagnostic) devices and reagens

  1. J

    Deciding between Professional Use or Lay Person IVD Test - Human fecal stool specimens

    Hello, I have a question regarding two of our IVD products using human fecal stool specimen The question is if the patient is provided a stand alone collection kit to collect their own fecal, then submit the specimen to test in the lab for diagnosis. Is the test considered professional use or...
  2. C

    Updates on Documentation for outsourced OEM from ISO 13485:2003 to ISO 13485:2016

    Hello Everyone, Our company is the legal manufacturer for some reagent kits and related instruments for IVD. We will be having the re certification for ISO 13485:2016, as we only had surveillance audit after the transition and we are not sure if we have sufficient updates on the documentation...
  3. D

    RUOs in IVD products

    My company is repackaging and distributing RUO products. A customer intends to use an RUO product in the IVD kit they are developing. Our facility handling this product is non-compliant to any quality standard. Although sold as an RUO, this customer wants us to acknowledge and agree that they...
  4. C

    How frequent to conduct Clinical / Performance Evaluation?

    Hello everyone, I'm new to the cove, as well as QA & RA, nice to meet you guys =]. My company designed and manufactured IVD kit and instrument, have been selling for a while and nothing has changed, while the clinical performance data and the referenced documents are dated back in...
  5. B

    MDSAP for OEM products in Canada for in vitro diagnostic test kit to include lancing device

    It's very normal case for in vitro diagnostic test kit to include lancing device. In our case, lancing device included in our test kit which is OEM product. I want to ask that OEM for lancing device needs to transition to MDSAP?
  6. Marcelo Antunes

    Informational EU Review and assessment of market surveillance activities 2014-2016 – Medical devices sector

    From document – Summary of EU Member States and EEA EFTA States’ assessment and review of the functioning of market surveillance activities according to article 18(6) of Regulation (EC) No 765/2008 for the period 2014-2016 Continue reading at the source... You may also comment/reply in his...
  7. Marcelo Antunes

    Medical Device News EU – Transition Timelines from the Directives to the Regulations – Medical Devices and in vitro Diagnostic Medical Devices

    Transition Timelines from the Directives to the Regulations – Medical Devices and in vitro Diagnostic Medical Devices Continue reading...
  8. M

    IVD Registration - Use of Prospective Study Data

    Hello all, It would be very helpful if you could address below query regarding the regulatory aspects of IVD device registration in South Africa, Kenya and Tanzania. Q1. Would it be possible to use prospective study data for in-country registration of an IVD? If yes, can you please let us...
  9. S

    Medical Device Research Use Only (RUO) label

    Dear all, I am a rather beginner in the regulatory affairs for IVD diagnostics and some questions which will come from my side may sound quite naive. We want to offer our products now also as RUO products. We have adapted the technical file, the SDS and now I want to adapt the labels. Having...
  10. N

    The question asks about sampling plans and AQL

    Hi there- I am working on a IVD disposable for which there is a categorical (pass / fail) test. I have looked at the standard sampling plans for relatively tight acceptable quality limits, and I find the output results to be slightly odd: the sample size doesn't go over a large range of lot...
  11. M

    What is Environmental intelligence specific to IVDs or Medical devices?

    Hello Team, What is Environmental intelligence specific to IVDs or Medical devices? Regards, Mallappa
  12. Marcelo Antunes

    Medical Device News New guidance sheets for the MDR/IVDR published

    New guidance sheets for the MDR/IVDR published Transition Timelines from the Directives to the Regulations - Medical Devices and in vitro Diagnostic Medical Devices - DocsRoom - European Commission Implementation Model for Medical Devices Regulation - Step by Step Guide - DocsRoom - European...
  13. A

    Examples of Pre-Sub, SRD, PMA Shells and Templates

    Hi, I am new to this Forum: I am a Regulatory Affairs Associate, I work in CDx and IVDs, and I am interested in examples of pre-subs, SRDs, templates and or shells for PMAs, 510Ks. Thanks in advance, Alessandra
  14. R

    Medical Device (IVD) - Selling RUO to Customers

    My understanding of MEDDEV 2.14/2 rev.1 2004 on RUOs is that as they have no medical purpose, CE marking to any of the three directives cannot be applied. My question to the forum is in two parts: 1) Can a validated IVD assay be re-labelled for RUO and sold to customers, as long as it is used...
  15. M

    RFID (Radio Frequency Identification) Registration in Europe and in MENA countries

    Hello everyone, I am not able to find answer for the following question. can someone help with the information? Q. What is the registration requirement for RFID (Radio Frequency Identification) and fees and validity of such registration in Europe, Tanzania, Ghana and Uganda? (applicable to IVD...
  16. N

    Essential requirements checklist needed?

    Hello, We had the first day of our ISO 13485:2016 audit today. Our business is a very small company who primarily assembles IVD's for self test use under contract from the manufacturer from CE marked components. This is not OBL, the manufacturer is named as such on the products and IFU. The...
  17. I

    Lot or Batch definition for IVDs

    US Regulation (21 CFR Part 820 (m)) Lot or batch means one or more components or finished devices that consist of a single type, model, class, size, composition, or software version that is manufactured under essentially the same conditions and that are intended to have uniform characteristics...
  18. I

    IVD prototypes in EU market

    Hi Folks, We are under the design process, designing an IVD device. This device is very similar to another device CE marking since 2011 (Designed and manufactured by us) but the intended use will be slightly different. We are planning to send prototypes to some key customers. This process will...
  19. N

    Own brand labelling/virtual manufacture of IVD's

    Hello, I would like some clarification please on what constitutes being " the manufacturer" of a self test IVD under the EU regulations. My company is currently negotiating the purchase of another small company (A) who assemble self test IVD's and distribute them under their own brand name but...
  20. F

    WHO (World Health Organisation) Requirements - Africa

    Hi all, I'm really struggling to understand WHO accreditation in relation to IVDs and shipments to Africa. Can anyone shed any light (or point me to a link) explaining what African countries require WHO and whether this is dependent on device classification etc? Really struggling with...
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