Medical product manufacturers are already confronted with lots of changes in the regulatory climate worldwide and especially in the EU.
medical ECONET GmbH is familiar with all obligations of the economic operators that are defined in the Medical Device Regulation (MDR) – be it manufacturer, importer, distributor or EC-Rep.
Our highly trained employees make sure that compliance is always kept, products reach our clients without delays, anytime, anywhere.
Our medical devices consultants in cooperation with our marketing department trade various medical products not only in Germany, but globally.
Our technicians provide qualified maintenance and repair services – on site and remotely. Logistics staffs make sure products reach our clients without delays.
Adopted in the early 1990s, the Medical Device Directive (MDD) served its purpose well and played a significant role in the success of the European medical device market over the past three decades. However, the MDD did not keep up with technological developments in the medical device space. More than that, MDD was a directive and it did not supersede the laws of individual European countries.
MDR is a much more complex and in-depths demanding process than MDD.
Manufacturers are not able to switch a system from one day to another, a realistic and patient oriented approach is essential. Due to the complexity of the MDR and the delay in the new system’s full readiness, European patients are losing their previous opportunities to be the first to benefit from critical medical technology innovation.
medical ECONET can assist you to open the door to European medical sector.
If you ask yourself: “What is different with MDR”?
- MDR is four times longer, and contains five more annexes than MDD
- Even existing MDD-products must be re-certified in accordance with the new regulations
- Update of technical documentation and especially clinical data and labelling are necessary
- More in-depth clinical data must be provided.
- Unique Device Identification (UDI) must be implemented
- The definition of medical device is broadened. It includes non-medical and cosmetic products that were not regulated previously.
- Manufacturers to permanently work with the European Database – EUDAMED
- IVDs are classified into four risk classes – A, B, C, D that will require notified body review for about 90% of all IVDs, up from the current 10%.
- Internal QMS processes must be revised. It includes risk management, Post-Market-Surveillance etc.
- With new classification rules some of the products will get higher risk class.
medical ECONET GMbH
medical ECONET acts as a manufacturer, an organization that fully sources its own named product from another company which has designed and manufactured an identical CE marked product. By placing our own name and address on the product, we take on the legal responsibilities for medical devices and are therefore regarded as the manufacturer.These include a full quality management system, application of conformity assessment, risk management, PMS, holding product liability insurance, having persons responsible for regulatory compliance (PRRC) and many more…Under previous MDD requirements there was no need of having an access to the whole technical documentation of the contract manufacturer. However, it changed with the MDR. By virtue of close cooperation with contract manufacturers all over the globe, thus bringing into compliance with the European and national requirements, medical ECONET has established its brand that became known in the healthcare sector.
... as your Distributor
- Does the product bear a CE symbol and has DOC been issued?
- Has the importer listed its name and address on the product, packaging and documents?
- Has the manufacturer issued a UDI? Is the product in compliance with the legal requirements?
All these questions distributors must ask themselves.
Distributor requirements significantly increased. We provide a high legal security for you, your company and your business!
medical ECONET offers:
- Sales activities
- Professional marketing of products in Europe
- Answering user questions
- Support in installation and commissioning, collecting and training
- Handling of customer complaints
- Feedback to manufacturer
- Translation of IFUs in multiple language
- Make references
and many more…
... as your Importer
MDR defines the roles and obligations of economic operators within the medical device industry.This also includes the role of the importer.
According to MDR „Importer“ means any natural or legal person established in the Union who places a product from a third country on the Union market.
With MDR an interaction between the importer, competent authorities and other stakeholders become inevitable
medical ECONET offers:
As an importer of your products, we make sure that they have been CE marked, EU declaration of conformity has been drawn up and EC REP is designated.
- Logistics services in all aspects
- Makes customs clearance
- Stores your products
- Meets your storage conditions
- Transports them to any destination in the EEA or beyond
- Grants traceability at any time Verifies products are registered in EUDAMED
We have the responsibility to keep a register and to inform manufacturers as well as their EC-Reps in the event of complaints. medical ECONET cooperates with all involved parties and grants access to the devices concerned.
... as your EC REP
EC REP is any person naturally or legally established in the European Community who is explicitly designated by the manufacturer to act on their behalf. This person may be addressed by authorities and bodies within the Community, instead of the manufacturer themselves, with regards to the requirements of MDR.The EC REP - European Authorised Representative may also be known as a EUAR, CE REP, EU REP and also an EAR. All of these mean the same; EU Authorised Representative. The role of a European Authorized Representative is both varied and challenging.
medical ECONET has considerable experience in representing companies in Europe. We’ll be glad to assist you!
medical ECONET offers:
- A thorough review of your EU declaration of conformity and technical documentation.
- Preparation and registration of the initial product in the electronic system EUDAMED.
- Update listing of product registration in the electronic system.
- Assistance in communication between the competent authority and the manufacturer.
- Assistance and coordination of complaint handling and incident reporting to the Competent Authorities.
- Updates regarding regulatory changes which might impact devices and registrations.
- Free Sales Certificates according to Art. 60 (EU) 2017/745.
Contact us!
medical ECONET GmbH
Im Erlengrund 16
46149 Oberhausen-Germany
Mail: info [at] medical-econet.com
Phone: +49 (0)208 / 377 890 24
Download or MDR Programm
Click here to download our full MDR Consulting Programm as PDF.
- Decide, which active and strategic roles shall be taken by medical ECONET
- Get in touch with us and get free consultation about the scope of cooperation
- Joint Gap analysis EU MDR 2017/745 vs. Status Quo and identification of pain points
- Creation of a strategy for closing gaps quickly
- Enter into a mutally beneficial legal agreement Work and grow together