class i medical device

  1. J

    FDA Class 1 Medical Device UDI requirements

    I have not found much information on Class 1 minimum requirements. I know the UDI contains the DI and PI but to what extent. Also we make product that could have a blue color, or a red, or a green, does that mean I need a separate UDI for all different colors and options? Just seems overkill...
  2. M

    How is Class I Medical Device Compliance Enforced?

    I'm curious: how is Class I device compliance enforced? Because NB is not involved, who (if anyone) would ever scrutinise a declaration of conformity or technical file? Is it the responsibility of the competent authority under which the device is registered? Assuming no adverse events, are...
  3. S

    Post Market Surveillance and Annual Product Review in ISO 13485

    ISO 13485:2016 states the following: 8.5.1 General The organization shall identify and implement any changes necessary to ensure and maintain the continued suitability, adequacy and effectiveness of the quality management system as well as medical device safety and performance through the use...
  4. Marcelo Antunes

    Informational ANVISA – Notification for Class 1 devices – Resolução da Diretoria Colegiada – RDC nº 270 de 28/02/2019

    Now all Class 1 devices required only notification. Agora, todos os dispositivos da Classe 1 precisam apenas de notificação. Resolução da Diretoria Colegiada – RDC nº 270 de 28/02/2019 Continue reading at Marcelo's website... You may also comment and discuss in this...
  5. S

    FDA Inspections and Pest Control - Pallets too close to walls

    My question relates to inventory organization with relationship to the FDA and pest control, specifically, placement of racks and/or pallets against internal and/or external walls. Background: My company contract-manufactures for multiple industries, including Class I medical devices. We don't...
  6. J

    IEC 60601-1 Electrical Safety testing - Class 1 ME externally powered - Earth resistance testing

    I'm running into an issue with electrical safety testing on a class 1 ME externally powered device. The device can operate both via a removable battery pack, or an external power adapter. The device is labeled as Class 1, however there are no exposed protective earth conductors on the chassis...
  7. J

    Steps when changing material for class 1 medical device

    Looking for information on steps when changing material for class 1 device. Change would be on some parts going from ductile to aluminum. Thanks
  8. J

    Virtual Manufacturer and CE Marking

    Hi, Does an OEM need a CE mark on their product in order for a virtual manufacturer to gain one? For clarity - the OEM has a FDA 510k on it, but the OEM has no intentions of selling in Europe themselves. However, the virtual manufacturer wishes to do so. Is it necessary for the OEM to gain a...
  9. N

    CE marking for distributed product

    Hi all, We've begun coming out of our virtual manufacturing agreements to "distributed by". On the latest shipment of a class 1 measuring device the legal manufacturer have applied our company name to the dial (in error) but their CE number. Can I legally place this product in the market place...
  10. A

    Class I medical device and Category III PPE - Long length gloves

    Hi All Covers, We wanted to produce a long length gloves that are both a Class I medical device and Category III PPE. This gloves will be packed in a dispenser. What would be the marking and labeling requirements for this glove? Should we label and mark on the glove itself? Does it need to come...
  11. M

    Notified Body Involvement with Self Declared Products

    Hi guys, If one of our Class I (self declare) products has a significant complaint (patient at risk, national authority is notified), is there auditor then allowed to question us on it even though it is not on our ISO 13485 scope and therefore not one of the products on their sampling list...
  12. S

    What is the significance of UDI date requirements for Class 1 devices?

    FDA issued a guidance establishing enforcement discretion that applies to FDA established compliance dates for certain class I and unclassified devices as set out below: Class 1 and unclassified devices manufactured and labeled on or after September 24, 2018 FDA does not intend to enforce...
  13. K

    Is a 3V torch classified as medical electrical equipment needing EMI/EMC testing?

    We have made a Class I (CE) metal medical instrument that has a plastic handle. With use, doctors requested a light option to improve visibility and to free up the hand holding the torch. We have incorporated a simple push switch and small light powered by standard 3V AAA batteries. The...
  14. J

    Class 1 Medical Device ECR (Engineering Change Request) Changes

    Class 1 device not requiring a 510k still be reviewed by regulatory per 878.9 for engineering change request? I would be using document k97-1 for guidance and documentation. Thanks
  15. S

    Clarity on requirements for a 510k exempt Class I device - Suture removal kit

    I'm wondering if anyone can provide some clarity on requirements for a 510k exempt Class I device - a suture removal kit. I need to know if the following are required for a device of this class: - Shelf Life testing - Sterility - Certificate of Analysis - Biocompatibility Testing Thank...
  16. M

    ISO 13485 Required for CE Mark on Class I product

    Hi guys, We were recently told by our Notified Body, in order to place a CE mark on our Class I product our critical subcontractor (we are the PLM) must have ISO 13485. Can anyone confirm that this is indeed the requirements? All this while we have understood self-declare to mean that we...
  17. K

    Why two fuses are required - IEC 60601-1 cl. 8.11.5

    Hi all, Why two fuses are required for Class I equipment, why not Class II. Kunal
  18. Lancaster

    GMDN code differences, Manufacturer and Sponsor

    Hi, Can manufactures and sponsors assign different GMDN codes? The situation is this: Class I Sponsor is in Australia Manufacturer is in Europe Sponsor has been assigning GMDN codes for a longtime as per the Aus regulatory system, they assign according the end product provided to...
  19. C

    Class I Medical Device ProCode JCB Question 2 (UDI)

    Where can I find information on which Class 1 510K exempt products will be included in UDI requirements come 9/24/2020? We have several JCB products that do not currently bear an UDI mark, and want to be prepared. Thanks!
  20. C

    Class I Medical Device ProCode JCB Question 1

    We are the manufacturer of detergents used in the medical and dental industries that are Class I, 501k exempt Medical Devices. Class I GMP Exempt Procodes.xls lists ProCodes exempt from 21 CFR part 820 and JCB is listed. Does this exempt us from having data to back up expiration dates that are...
Top Bottom