mdr (medical device regulations)

  1. Marcelo Antunes

    Informational EU MDR and IVDR Factsheet for healthcare professionals and health institutions

    Factsheet for healthcare professionals and health institutions Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  2. L

    Clinical Investigations under MDR

    I am having a bit a trouble identifying in the MDR when the requirements for clinical investigations are effective. Article 120 (transitional provisions) says: " By way of derogation from Article 5 of this Regulation, a device with a certificate that was issued in accordance with Directive...
  3. M

    MDR Annex IX Chapter I, 2.2 (c) - Device identification procedures during manufacture.

    I hope you'll be able to help. The MDR fog has descended today and I'm struggling with a sub-section (see bold red text below) of Annex IX Chapter I, 2.2 (c). (page 147 of the MDR). Here's the context: 2.2 (c) the procedures and techniques for monitoring, verifying, validating and controlling...
  4. Marcelo Antunes

    Informational Next meeting of the Medical Device Coordination Group (MDR/IVDR) – 20 June 2019

    The next meeting of the MDCG is schedule for 20 June 2019. Some guidance are up for endorsement: Vigilance: Manufacturer Periodic Safety Report (MPSR) form – for endorsementImplant card guidance Guidance on Summary of safety and clinical performance Person responsible for regulatory...
  5. Q

    MDR Effectivity date for Legacy Class I Medical Devices

    Currently we have Class I products self-declared under the MDD for the past 5 to 10 years. Do these products have to be compliant with the MDR from May next year or is there a transition period? We are certified to ISO 13485 with a NB.
  6. Marcelo Antunes

    Informational EU – Medical devices: Implementation of Regulation (EU) 2017/745 on medical devices (MDR) – Information from the Irish and German delegations

    Medical devices: Implementation of Regulation (EU) 2017/745 on medical devices (MDR)- Information from the Irish and German delegation Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  7. M

    Referencing the MDR by name in QMS SOPs

    When updating Quality System SOPs, whose scope covers both EU and US regs, as part of preparation for the MDR, does the MDR introduce a requirement that this EU regulation, i.e. 2017/745 is called out by name in areas that currently refer to 'regulatory requirements'? E.g. in a procedure...
  8. S

    Dual MDD and MDR certification

    Presently I work for a company that manufacturers a number of medical devices and the plan is to continue to sell into the EU under the MDD during the transitional period and transfer to the MDR at a later date. As part of the transition rules we cannot make significant design changes to...
  9. C

    If it's not a custom-made medical device... What is it? Clinician requests

    I've poked around on Google quite a bit trying to find an answer, but have failed miserably to find an answer. I'm trying to wrap my mind around the MDR as a whole, and this has me tripped up. According to Article 2 (3) "mass-produced devices which need to be adapted to meet the specific...
  10. Marcelo Antunes

    Informational EU – M2M Data Exchange available services for accessing MDR EUDAMED data available for Economic Operator (EO) organisations

    M2M Data Exchange available services for accessing MDR EUDAMED data available for Economic Operator (EO) organisations Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  11. I

    2017/745 (MDR) - Instruction for use (IFU) - manufacturer's website

    Hi, I am wondering if the IFU and operator manual must be on the manufacturer's website under the new MDR (concerning a class IV MD)? Or do we have to make available on the website just the information below and not necessary all of the IFU and the operator manual? In the case of a eIFU with...
  12. Marcelo Antunes

    Informational New Notified Body designated under the MDR – TÜV SÜD Product Service GmbH Zertifizierstellen

    New Notified Body designated under the MDR – TÜV SÜD Product Service GmbH Zertifizierstellen Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  13. Ajit Basrur

    Informational TÜV SÜD Becomes Second NB to be Designated Under EU MDR

    Germany-based TÜV SÜD Product Service GmbH Zertifizierstellen on Wednesday became the second notified body (NB) to be designated and notified under the EU Medical Devices Regulation (MDR), which goes into effect next May. TÜV SÜD is now listed alongside BSI UK, which was the first NB designated...
  14. Marcelo Antunes

    Informational Medtech Europe guidance – Use of Symbols to Indicate Compliance with the MDR

    Use of Symbols to Indicate Compliance with the MDR Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  15. C

    MDR Importer/Distributor Definition Questions

    I have a question that I am hoping someone may be able to answer. The first is the definition an "importer" as used in the MDR. It states: "importer" means any natural or legal person established within the Union that places a device from a third country on the Union Market: " My question is...
  16. Marcelo Antunes

    Informational EU – Corrigenda for MDR and IVDR published in Official Journal

    Corrigenda for MDR and IVDR published in Official Journal Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  17. Marcelo Antunes

    Informational EU – EUDAMED UDI Device Data Dictionary + data sets

    EUDAMED UDI Device Data Dictionary MDR – UDI and device data sets to provide in EUDAMED IVDR – UDI and device data sets to provide in EUDAMED Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  18. M

    EU MDR - UDI requirements and responsibility guidance

    Hi Everyone, Can someone point me in a direction if the EU MDR has a guidance that specifically states anything about UDI responsibility? Our company is the legal manufacturer and our distributors are the UDI partners. My question is if our company can delegate this responsibility to our...
  19. C

    Usability IEC 62366-1:2015 and MDR 2017/745 - Risk based approach

    Hi everyone, We have a Class IIa Medical Device that it is a wipe to apply on the skin. We have a few risks of use error with this product because the user interface is very simple and easy to understand... Based on the first risk analysis of the product, do you think that I can avoid...
  20. M

    New medical device on the market before MDR

    Can a manufacturer (with MDD certificate valid till 2023) place a new device, complied to MDD, on the market in before May 26 2020 referencing MDR grace period? What about technical file assessment (from Notified body's side) of this new device? Could it be done according to MDD even after may...
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