class i 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

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...

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...

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...

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...

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...

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

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...

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...

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

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...

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!

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...

Greetings, I work for a very small medical device startup that is currently preparing for placement of a CE mark on our Class I device. I'm new to the CE marking process and understand the basics, however, I'm currently struggling with writing the CER to the MEDDEV 2.7/1 Rev 4 guidance...

Greetings - I'm writing my first technical file following the STED format for a Class I, non-sterile, non-measuring device. According to the guidance document for STED, the document should contain an overview of previous generation(s) of the device, if such exist. We do have a previous...

Dear community, Our company is manufacturing a Class I active device which measures just 25mm (length) x 15mm (width) x 10mm (height). Some surfaces are furthermore impractical to print any information on. The re-usable device will be used by non-professional users and packaged individually...

Hi All, If Company A buys the entire rights (design, trade name, technical file, manufacturing etc.) of a class I medical device from Company B, does Company A need to re-label any historical stock of the product they acquire during the purchase with their name and address before being able...

Hello everyone! I may show my inexperience with question, but the time has come to ask. I'm a single-person QA/RA unit and am putting together my first technical file documentation for a Class I, non-measuring/non-sterile device. However, the device is electronic and I understand that we...

8.11.5 * Mains fuses and OVER-CURRENT RELEASES A fuse or OVER-CURRENT RELEASE shall be provided in each supply lead for CLASS I ME EQUIPMENT and for CLASS II ME EQUIPMENT having a functional earth connection according to 8.6.9, and in at least one supply lead for other single-phase CLASS II...

Daer all, I have a case where a manufacturer of medical forceps [class I] Is looking to add into its IFU a section stating that his forceps can be used also for pushing/withdrawing a fiberoptic camera [Nasopharyngoscope = class II] into the nasal cavity, when the M.D. is taking care that no...