MedicalMountains supports the member companies with advice and action.
- ExpertTable MDR
The ExpertTable MDR is to be launched in 2018. Its Task Force – a fixed, already existing core team – consists of specialists from large and medium-sized medical technology companies. Monthly meetings focus on processing various key topics of the EU-MDR in order to support the timely and professional implementation in terms of pragmatic references, templates and guidance. All medical technology companies whose products fall under the MDR 2017/745 can profit as a “passive member”, of the complete knowledge of the ExpertTable. For an annual fee of € 1,000 plus VAT, you will have access to the monthly publications. MedicalMountains will gladly accept your questions and registrations for passive membership by e-mail!
Download: Flyer ExpertTable MDR (in German)
- Checklist for European Medical Devices Directive
What must medical technology companies pay attention to in the context of the new European Medical Devices Regulation? Below you will find a checklist, which provides a first orientation and helps to identify your own fields of action.
Download: EU MDR Checklist for orientation (in German)
- Add On Checklist for Class Ir
While the “Checklist” looks more at general aspects of the EU-MDR, the so-called “Add On Class Ir” specifically targets manufacturers, distributors and suppliers of reusable surgical instruments. Its purpose is to help OEM and PLM manufacturers to take first actions towards a status-quo. The checklist can be requested here by e-mail.
- NEW: Step-by-step EU-MDR Guideline
A “step-by-step EU-MDR Guideline” is now published: In form of a tabular list, the current requirements for Class 1 medical devices will be compared to the new specific EU-MDR guidelines for “reusable surgical instruments” of the Ir class. In this way, companies are able to process for them relevant aspects in a logical and chronological order i.e. step-by-step. In addition, three comprehensive checklists are included: security and performance requirements, technical documentation and post-market technical documentation.
The guideline costs 320,00 Euros (plus VAT) and 290,00 Euros (plus VAT) for TechnologyMountains Members. Passive members of the “ExpertTable EU-MDR”, organized by MedicalMountains, receive additional 20% discount.
The guideline can be requested per email. Please submit the signed confidentiality declaration (Geheimhaltungserklärung Schritt Für Schritt Leitfaden, in German).
- NEW:Free legal advice for MDR (VO 745/2017)
MedicalMountains AG offers free legal advice for medical technology companies whose products fall under the new MDR (VO 745/2017). In half-hourly individual consultations, interested parties receive initial information on regulatory issues relating to the new MDR (VO 745/2017) and the various roles or business models that companies can and want to take under the new EU regulation. In addition, new liability risks, caused by the MDR, will be identified. As a consultant, lawyers from the law firm of Friedrich Graf von Westphalen and partners from Freiburg are available for you as volunteers.
Click here for registration.