There are now 4 notified bodies for the Medical Devices Regulation: BSI (UK), DEKRA (DE), TUV Sud (DE) and IMQ (IT). BSI wrote that they accept new applications but it seems that priority is given to existing customers. The list of notified bodies is avalaible on the NANDO website.
The new Medical Device Regulation (MDR) in Europe requires the manufacturer to keep records during 10 years (15 years for the implants). Previously (MDD), this retention period was only 5 years. Impact : you have probably documented this retention period in your Quality Management System (in your procedures or in the documents list). Update your documents. Verify also your contracts with distributors or subcontractors. They have also to keep some records. Retention time must be documented (and updated accordingly).
If you are located in Wallonia, you may be eligible to the « Chèques-Entreprises » program. They have recently updated/simplified the different options. See the Website (https://www.cheques-entreprises.be/ ). EngiMed is still accredited to help you in the setting of your Quality Management System. Feel free to contact us.
European Commission has prepared a Corrigendum to extend the transition period for the medical devices that were classified in Class I according to MDD and that become Class II or higher in the new Regulation. If it is confirmed, it will be a good news for the medical software manufacturers.
Triaxes is a program supported by the Brussels Region. Triaxes bring to your development project the help of a multidisciplinary team : engineering, industrial design and business developer. Triaxes makes accessible the development method used in very creative companies (Decathlon…). Check how Triaxes may help you by visiting the website -> click here