Search the Elsmar Cove!
**Search ALL of Elsmar.com** with DuckDuckGo including content not in the forum - Search results with No ads.

Custom made medical device MDD vs MDR definition

#1
Hello everyone

My organization manufacturers sockets for patients who have lost a limb. The socket covers the patients residual limb, and is then fitted with other parts (including a hand or a foot) to create an artificial limb for the patient.

These sockets are individually made using a traditional lamination process by draping material over the cast of the patient's residual limb. As you can imagine this socket is made to the 'prescription' of the clinician and thus is a custom-made medical device, and doesn't bear a CE mark.

Two questions really....

1. Does the classification of custom made device change under the revised wording of MDD (custom made/mass produced)?

2. If we were to create 3D printed sockets, would this become a mass-produced device and hence require the application of the CE mark (class 1 device)

Thanks in advance for your thoughts.

James
 
Top Bottom