MedicalMountains supports the member companies with advice and action.
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)
NEW: Online-Tool for first orientation EU-MDR
What requirements must medical technology companies face in the course of the new European Medical Devices Regulation? Below you will find an online tool that provides a first orientation and shows you the necessary tasks for implementation. All this you get in a finished generated PDF.
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.
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).
Free legal advice for MDR (VO 745/2017)
MedicalMountains GmbH 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.
NEW: Free Regulatory Affairs Check-up
MedicalMountains offers a free check-up with Medidee Services.
Benefit from a one-to-one personal exchange with Medidee Services experts on Regulatory Affairs topics such as:
- Impact of new European regulations (MDR & IVDR) on your products (considering quality and clinical aspects)
- Regulatory positioning and strategy for market release
- MDSAP prepared and audits exist
And much more …
The one-to-one talks take place from 13:00 to 17:00
MedTec Excellence within the "go-cluster" program
Developed and implemented
- a consultant label specially tailored to medical technology for selecting and comparing required external expertise,
- a digital orientation guide to the EU MDR,
- free legal advice on the EU MDR,
- offers for professional GAP analyzes.
Community Clinical Evaluation Ir
The EU MDR requires medical device manufacturers to conduct a clinical evaluation regardless of the risk class. It is an integral part of the manufacturer’s quality management system. The clinical evaluation represents a systematic process for generating, collecting, analyzing and evaluating the clinical data on a product
- Prove safety and performance requirements,
- to exclude unwanted side effects and
- prove the benefit-risk ratio.
The required clinical data can be collected by
- clinical trials on the product,
- Information collected through post-market surveillance,
- Specialized literature on clinical trials or studies on a similar product or other clinical experience with your own or similar product.
The clinical evaluation can also be done jointly. The principle: As a neutral player, MedicalMountains collects a pool of interested parties from various manufacturers with a comparable product portfolio. With a sufficient number, an external service provider will be commissioned to provide the clinical evaluation. Joint assignment divides the clinical score by the number of participants.
A joint clinical evaluation according to MEDDEV 2.7 / 1, June 2016 has already been initiated for laparoscopic instruments. One of the next steps will be followed by a collaborative clinical evaluation for product class Ir. Participating companies not only save money, but above all time to have their Ir products certified in time before May 2020.
Are you interested in joining the Community Clinical Assessment Ir? Then send us an e-mail!