mdd (medical device directive)

  1. M

    CER (Clinical Evaluation Reports) updates - Product Codes

    Hello Everyone, We are currently submitting for MDD cert for one of our products. Just before we release we realise that we can add additional product codes to the existing CER. So now we're doing a gap analysis to add the product code to the submission file as well as update the existing CER...
  2. 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...
  3. T

    EU Regulation 207/2012 - EIFU - Customer Requests

    Greetings, I am working to implement our eIFU program in accordance with EU Regulation 207/2012. Currently, our IFUs are offered on our website, but I'm working to set up a program to handle customer requests for printed copies. However, I have a conundrum... Since our company is extremely...
  4. 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...
  5. E

    EU Class 1s CE Mark Regulatory Pathway

    I am working on a new product that is a class 1s device and we are seeking CE mark. What are the available regulatory pathways and involvement of the NB?
  6. K

    Obligation for Distributor in MDD/MDR

    We are manufacturer of Medical device Class IIb and facing one situation related to the exported machines. Please suggest if our dealer does not disclose the customer details to us & they don’t do the preventive maintenance of those machines properly. So in case of any adverse incident happens...
  7. M

    Authorised Representative Contact Information

    Curious: I've been scanning the MDD, MDR, and MEDDEV 2.5/10 for references to required Authorised Representative contact information, and all I can seem to find is that only name and address are required. Is this correct? Aren't they are supposed to be contactable within a timeframe from...
  8. D

    MDD to MDR - Technical File conversion

    I already have a Technical File for the MDD. But to comply with the new EU MDR, I will need to convert the documents to follow the updated requirements. The data and records are all there thanks to the gap analysis we did earlier, but I would like to know how everyone is handling conversion of...
  9. T

    CE Certification Strategy - Expanding the validity of certificate

    Hi All, Our organization`s CE certificate getting expiry by December, 2020. Now what is the safer side of expanding the validity of certificate? By using again MDD re-certification audit or MDR complete transition and then audit? Also MDR till date no detailed guidelines will be available. Also...
  10. S

    Checklist for MDD to MDR gap analysis

    Hi Folks, Has anyone seen. a Checklist for MDD to MDR gap analysis? We are getting close to the transition time. Thanks, Shimon
  11. 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...
  12. Marcelo Antunes

    Medical Device News Medical Device Directives – New templates for Field Safety Notices published

    The EU Commission published some new templates for Field Safety Notices related to the current medical device directives and MEDDEV 2.12/1 rev.8. template links are below (they can also be found at: Guidance - Growth - European Commission). A Comissão da UE publicou alguns novos modelos para...
  13. Rincewind

    Pressure energy - Essential Requirements (MDD/MDR)

    Hello, I was wondering if a device that puts pressure on a patients limb, for example would have to be considered under Annex I MDD (12.8.1.) or respective Annex I MDR (21.1.) "21.1. Devices for supplying the patient with energy or substances shall be designed and constructed in such a way...
  14. I

    MDD Class I software technical documentation sample

    Hello, I have a question regarding technical documentation for MDD Class I software, specifically Device description. How detailed must be the individual parts of the device description such as general description, intended use ect. Are there any specific content requirements for each of these...
  15. TechnicalGuy

    Information regarding Nanomaterials in Medical Devices

    Hi Covers, Was hoping someone would be able to point me in the direction for information regarding nanomaterials in medical devices. What is the current legislation under the MDD? What is it in the MDR? What additional information is needed when a device incorporates a nanomaterial and where is...
  16. M

    Putting AR's name and address on label - Authorized Representative Labeling Requirements

    Hi, I have the following questions on putting the AR's name and address on label We are a manufacturer based out of EU manufacturing class 1 and 11 a 11b products Some of our products are self certified and we just put CE logo on the other products we put CE logo along with NB number. As per...
  17. T

    Effective Date on Documents

    All, Please correct me if I'm wrong - within 21 CFR 820, ISO 13485:2016, and the MDD, I cannot find that having the effective date on a document is required. All that is required is that the document was reviewed and approved, has an identifier (e.g. name, number, revision level, etc.)...
  18. W

    CE Mark for Class III Medical Device - MDR or MDD applies?

    I am getting my ISO13485:2016 following the MDR which I will obtain by 1st quarter of 2019. I will then apply for CE Mark which will be under MDD 93/42/EEC as the CE Mark under MDR is not effective yet till May 2020. So the question is will I be able to apply for CE Mark under MDD 93/94/EEC with...
  19. V

    How do I get a rough MDD to MDR gap analysis by clauses

    Hello, how do i get a rough MDD to MDR gap analysis by clauses which will be helpful for us to undergo the transition?
  20. G

    Medical Devices: Product/Production Quality

    Dear all, Situation: a medical company (the developer) develops a medical device class IIb for the EU market (MDD) but is not yet ISO 13485 certified but will be very soon. Production is outsourced to a company (the producer) that is ISO 13485 certified. Now the full-compliance testing (EMC...
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