Will ulrich medical supply all products after 25 May 2021?
Individual products are currently in phase-out. This was announced to all ulrich medical customers at an early stage.
We are working on making all other products available for the future under the new MDR legislation.
Can you provide us with an ulrich medical MDR certificate?
MDR certificates are issued per product category. The first certificate for ulrich medical will cover instruments class Ir. All other certificates will have been issued by 2024 at the latest.
We will inform you immediately when a new certificate has been issued.
In the meantime, the products can still be placed on the market under MDD.
Do we become a manufacturer after reprocessing if we use non-sterile implants?
No, you do not become a manufacturer, as you do not reprocess already implanted single-use devices. Since there are many individual details and constellations to this question, your sales representative can personally answer the specific questions on this with information on the legal basis.
How often may implants be reprocessed?
There is no regulation on how often implants may be reprocessed. However, restrictions must be specified by the manufacturer for MDR-compliant products.
Instruments are reprocessed. What is the difference to implants?
Unlike implants, instruments are reusable products. Here you must follow the manufacturer’s prescribed reprocessing instructions so that the instruments remain usable.
Contact
You have not found the answer to your questions? Then contact your sales representative who will answer your individual questions in this regard. Or contact our MDR expert service!
