ce mark and ce marking

  1. J

    EC REP information and CE Mark - Component of a system that is not a medical device

    I joined a company not long ago. The company markets an old electrosurgical system that includes a cart with its own SKU. The cart is not considered a medical device. The label for the cart lists the EC REP and no CE mark. Is this correct? Does the EC REP need to be listed if the...
  2. P

    CE Marking EN ISO 13849-1: Electrical Panel behind interlocked doors

    Anyone know if having a machines main electrical panel behind interlocked enclosure doors contravenes the machinery directive and therefore interferes with CE marking? Basically it means that the panel is only accessible once the machine is estopped or the mains electrical isolator/disconnect...
  3. F

    Interpretation of MDR 2017/745 Article 23 - CE Mark Requirements

    Hello Everyone, I am in the middle of an MDD audit and my NB has dropped a huge bombshell with regards to the upcoming MDR which I disagree with. I would appreciate it if anyone could shed some light on what their interpretation or their NB's interpretation of article 23 is. My NB has advised...
  4. K

    Supplier Controls for Animal Tissue Suppliers for Medical Devices

    Good morning, Can anyone tell me or point me in the direction of a good resource on supplier controls for animal tissue suppliers for medical device. What registrations do they need to have? Certs? What CoCs should we request and so forth. TIA
  5. C

    Is CE Mark needed for a small DAC audio board on top of a Rasberry PI?

    Hi We are the manufacturers of a small DAC *(audio board) that only works when plugged into a Rasberry PI. It has a 5V input and no wireless .Do we need a CE mark ?
  6. B

    Do CE Mark associations exist?

    Do CE Mark associations exist? If so, does anyone have a recommendation? Thank you in advance!!! Bradford
  7. P

    Non-Active Suppliers on CE Certificate

    If a supplier is listed on your CE certificate but are no longer active ie you are not buying from them, can you remove them from the certificate if you are still placing products on the market which contain the supplier's components? Our NB is BSi. Thanks
  8. P

    Calculating a weight for a machine for the CE label

    Building a machine that is made up of 2 primary units. The first is a main enclosure which is contains the majority of parts inside double interlocked doors. The second is a standalone unit which we purchased from a supplier and as such is integrated into the main unit. It generates hot or cold...
  9. 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?
  10. E

    MDR Article 117 / Impact to New Marketing Authorization Applications

    How will the medical devices Regulation - in particular Article 117 - impact new marketing authorization applications?
  11. K

    Distribution medical devices to US Embassies

    Hello, Does anyone have experience or some evidence of FDA's stance on distributing to US Embassies in other countries without following the regulatory pathway to distribute to the country in which the US Embassy is located? Hypothetical example, let's say I have a Class 2 Med device that is...
  12. L

    Class IIa Medical Device, CE Mark & 510k - Labeling Content

    We have a class IIa medical device with CE registration and 510k filing underway. For the 510k filing the IFU and labelling had to changed with among those changes a Rx only symbol. This triggered a discussion as the inteded use of the device contains: "shall be used in a clinical environment...
  13. R

    List of countries that require only CE Mark certificate for product registration

    Hi, I would like to know about the list of countries that requires only CE certificate for product registration?
  14. M

    CE/FCC/Industry Canada - Standards required for Certification for a Bluetooth Device

    Hi, I am working on certification for a Bluetooth Device. I have received FCC rule 15 'approval' and a CE Mark. For Industry Canada it is sufficient to show harmonization with our current certifications. Does anyone have a chart illustrating the harmonized standards with Canada and the...
  15. S

    PMCF (Post Market Clinical Followup): Rationale for Exemption - Software Medical Devices

    Hello there, Our ISO13485 company manufactures a software medical device of class IIa and we based the compliance for the CE marking basing on equivalence. Also, our product can be considered as "Low Novelty". We have a robust Pre-market clinical data and our conclusion (approved by BSI) on...
  16. H

    Safety and efficacy study for CE marking

    Hello, We have a Class IIB medical device which we will be taking to in-vivo trial soon. Obviously there is no straight answer here, but what sample size is generally accepted by EU/US to claim that the device is safe and effective? Many thanks.
  17. 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...
  18. K

    Post Market Clinical Follow up and CE Marking for Class IIb medical X-Ray products

    Hi Everyone I want to know about Post Market clinical Follow up and CE Marking for our Class IIb medical X-Ray products. As per our understanding PMCF (Post Market Clinical Follow Up) study is required for devices based on Novel Technology & it is also needed for the Class III, Implantable...
  19. B

    Stability testing of medical devices as per ASTM F1980-16

    Recently, we got audited for CE mark and our products are polymeric based sterile devices. During audit, auditor asks for the humidity levels for the product and as per ASTM 1980 humidity is not a mandatory requirement to be considered for testing and ASTM considers only temperature based on...
  20. J

    CE Marking for vibrator personal pleasure toy

    Hello, It is my first thread in here. I was asked by an aspiring client to prepare documentation for CE marking of a vibrator pleasure toy, vibrator class 2 non implantable device. It has low risk battery. I haven't been able to locate the corresponding directive and have no previous...
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