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Medical Device Regulation, Newsletters

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.

Newsletters
You have now free access to the GMDN database -> click here . This codification is used world-widely. Despite it comes a little bit too late for the European Commission that has selected the Italian codification (CND) as part of the future Eudamed database, it could be useful for you to confirm the GMDN code of your products. Indeed, the CND nomenclature will be mapped to the GMDN.
Medical Device Regulation

BSI is now accepting applications for MDR. This service will focus on their existing UK (0086) and NL (2797) clients.

Medical Device Regulation

With BSI (UK), TÜV SÜD (DE) becomes the second notified body to be certified under the new Medical Devices Regulation (MDR). Still nobody for the IVDR

Newsletters
End of 2018, a new version of the Field Safety Corrective Action and the Manufacturer Incident Report has been published by the Competent Authorities. The templates could be found here. You probably make reference to these documents in your Quality Management System (Vigilance process). Make sure you have the latest version available. A set of procedures and forms is available at EngiMed. Don’t hesitate to contact us.
Newsletters

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).

ISO certification, Quality Assurance, Subsidies

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.

Medical Device Regulation

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.

Engineering, Subsidies

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

Training

DM experts organizes a training (in French) related to the new Medical Device Regulation. It is a good way to start the long journey in the land of the MDR.

Event

MedTech Meetup is coming back (20/03/2019). EngiMed will be present in the experts corner. If you have any question about the medical device regulation, technical files or quality management systems, feel free to visit us. Website http://www.medtechmeetup.com/