Did you know that EngiMed and Covartim collaborate since a long time in a respectful a partnership ? Accepting me as COO of Covartim, Kyun Thibaut give me the opportunity to make this link stronger than ever. EngiMed and Covartim have put in common their resources, building a collaborative Quality Management System documentation that is continuously improved through our experience on the field. Want to discover it?

Sahar has joined the forces of one of our customers. Sure she will continue to ease the implementation of the Quality Management System and bring her good mood to the team. I wish her full success.

Wow, it’s been a long time since we’ve given you some news. Our Quality Management System has been adapted to fulfil the requirements of the ISO2200 on Food Safety Management. Feel free to contact us in case you need an easy way to implement rapidly a quality management system in your organization. (medical devices, in vitro diagnostic devices and now, foods and food supplements).

We would like to share our experience with the Notified Bodies that have been contacted for a CE marking under the MDR. BSI (UK) and DEKRA (DE) don’t take new customers. TUV Süd indicates they need some time but they expect to be ready beginning of 2020. IMQ (IT) cannot be contacted. TUV Rheinald is the only Notified Body that has received our CE marking request positively. Today, NANDO identifies 2 new Notified Bodies: BSI (NL) and DARE!! (NL) (honnestly, never heard about DARE!! before).

Very happy to have Julie Humblet joining EngiMed for an interim mission. Julie will give a welcome boost for the transition of the Quality Management System towards the MDR requirements (PMS, PRRC, Vigilance…).

Maybe this list may help you a little bit:

TÜV Rheinland LGA Products GmbH ; https://www.tuv.com/world/en/eu-medical-device-regulation-mdr-2017-745.html

DEKRA Certification GmbH ; https://www.dekra-certification.de/medical-devices-manufacturers/regulation-on-medical-devices.html

IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. ; https://www.imq.it/en/eu-directives/regulation-medical-devices-mdr

TÜV SÜD Product Service GmbH Zertifizierstellen; https://www.tuvsud.com/en/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification/medical-device-regulation

BSI Assurance UK Ltd; https://www.bsigroup.com/en-GB/medical-devices/our-services/ce-marking/

The new Regulation requires manufacturers to add new information on the label: the fact that the device is a medical device, that the device contains materials of animal origin… The MedTech Europe has published a guideline. The proposed symbols are not yet official. We can hope they will be incorporated in the revision of ISO 15223-1.

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 available on the NANDO website.

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.

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

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

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.

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

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.

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/