european union

  1. S

    Difficulty Finding A Notified Body for CE Marking - No Capacity

    Edit: medical devices We are having difficulty finding a notified body that is willing to accept our product(s) for CE marking purposes, due to lack of capacity. Our company is based in London, and would prefer to use a NB located close by (though, we are willing to go farther afield if...
  2. Marcelo Antunes

    Informational EU – Draft Functional specifications for the European Database on Medical Devices (Eudamed) – First release (High(1)) to be audited

    Draft Functional specifications for the European Database on Medical Devices (Eudamed) – First release (High(1)) to be audited Continue reading at Marcelo's Medicaldevice.expert website... You may also comment and discuss in this discussion thread.
  3. Marcelo Antunes

    Informational EU – SCHEER – Minutes of the Working Group meeting on guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devic

    SCHEER – Minutes of the Working Group meeting on guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices of 8 January 2019 Continue reading at Marcelo's Medicaldevice.expert website... You may also comment and discuss in this discussion thread.
  4. TheMightyWife

    Discontinuation of a Medical Device in EU

    I went through all available info on the wide world web and can't find any guidance, steps... We are planning to discontinue all medical devices we manufacture with immediate effect (as soon as practicable). These are majority of Class I and 3 IIa, plus 1 class Ia (measuring). I can't find any...
  5. Marcelo Antunes

    Medical Device News EU interesting developments – embracing MDSAP and UDI alignment

    Medical Devices: The EU will take steps to make use of single audit reports (an initiative of the International Medical Device Regulators Forum – IMDRF) in a manner that is compatible with EU legislative requirements. The EU and US will cooperate to ensure alignment of electronic database...
  6. Marcelo Antunes

    Medical Device News EU – MDCG 2019-1 MDCG guiding principles for issuing entities rules on Basic UDI-DI

    MDCG 2019-1 MDCG guiding principles for issuing entities rules on Basic UDI-DI Continue reading...
  7. T

    Change to Country of Origin on Medical Device Labeling

    Would a change in country of origin require notification to any of the MDSAP jurisdictions and/or the EU? The change has been approved by CBP, but didn't know if this labeling updating would require further notification since there is no safety-related update. Thanks!
  8. Marcelo Antunes

    Informational First NB designated to the EU MDR regulation – BSI UK

    Primeiro NB designado para o MDR – BSi UK First NB designated to the EU MDR regulation – BSI UK http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34 Continue reading...
  9. M

    SOPs, Plans and Report templates for Clinical Evaluation of EU MDR

    Dear all I am looking for SOPs, plans and report template for Clinical Evaluation related matters of MDR (i.e. Clinical Investigation, PMS, PMCF, CER, PSUR etc.) Does anyone have these I can use? If not, I see that A.P.Lyon (from the US it seems) are selling SOPs for the entire Clinical...
  10. S

    Clinical evaluation for a class IIa medical device - EU MDR Requirements

    Hello, Our company has an EC certification of a class IIa device under MDD and we are considering to continue putting it on EU market under MDR. Recently in seminar we`ve heard that to comply with MDR`s requirements on clinical evaluation, a paper of this device is necessary (at least one...
  11. C

    Do Distributors need to register with competent authorities in the EU?

    In addition to selling our own manufactured products in the EU, my company is planning to re-sell/distribute a product on behalf of another manufacturer. We are already fully ISO 13485 certified and CE marked (for our own product) and the partner company product is also CE marked and they (as...
  12. C

    Can we be our own EU authorised representative?

    Hi, Does anyone know if a non-eu based manufacturer opens up an office in the EU - does this mean an authorised rep is not needed or, if it is needed, can the EU office be the authorised rep? Thanks
  13. 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...
  14. R

    ASQ, CQI,............where else

    Hi fellow Elsmar forum team members, I have been loitering for years around Elsmar and learning a lot from many other's questions and the knowledgeable answers. I now have a question of my own that I cannot find an answer to elsewhere, so here goes............. I have a team of quality...
  15. N

    EU Authorized Representative question

    Hi all, With the chaos surrounding the UK government trying to implement Brexit the business I work for (based in the UK) has reached the point where we are assuming no deal will be struck and are in the early stages of planning. This leaves the challenge of appointing an EU rep. Is there a...
  16. shrutisancheti

    EU User manual / operator manual / service manual guidance document(s)

    Hello All.. Is there any specific guidance document(s) available, which explains/lists the essential contents of the user manual/operator manual/service manual for a medical device to be marketed in Europe. Please help. Thank you in advance. Best regards, Shruti
  17. T

    Research Medical Device EU - Requirements and Regulations

    Greetings! Does anyone know what the EU requirements are for exporting a device (non-IVD) that will be used for research? Is the device required to be part of a clinical trial? What would the requirements be for an academic institution to use the device? Any assistance would be most...
  18. E

    Electrical safety (battery-powered medical device)

    Hello all, Is it necessary in the EU to test the leakage current for a battery-powered medical device for compliance? Thanks.
  19. M

    IVD - Generating clinical data for IVD’s in the EU

    I hope you’ll be able to provide some advice. Could you point me in the direction of useful guidance documents / articles that detail requirements / the process for generating clinical data for IVD’s in the EU. I am familiar with the process for obtaining pre market and post CE approval...
  20. H

    EU Medical Device Regulations (MDR) Checklist

    Hi All, Does anyone have EU MDR (Medical Device Regulations) Checklist ?
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