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Medizin & Regulatorik
If your in vitro diagnostics and medical devices are on the market under the EU-IVDR/MDR, you have already largely implemented the resulting requirements of the MepV & IvDV.
Your products must be compliant for the Swiss market and your QMS may need to be adapted to reflect the regulatory requirements of the IvDV and MepV.
We recommend starting with a gap analysis and reviewing your current documentation. Our MepV and IvDV department supports you in developing and successfully implementing a compliance and regulatory strategy.
ELLECOM will act as your Swiss authorized representative (CH-REP) in Switzerland. MepV and IvDV now require a completely new role: the Swiss Representative (CH-REP). Similar to the EU representative, this is the legal representative of the manufacturers of medical devices and in vitro diagnostic medical devices in Switzerland.
As the manufacturer, you must determine the correct classification yourself. The Notified Body is not allowed to provide support in this matter. Our team supports you in the correct classification of your medical device. Art. 15 MedDO and Annex VIII of the EU MDR as well as Art. 14 IvDV and Annex VIII EU IVDR are decisive for the classification.
Clinical trials and performance studies are conducted in Switzerland or in other EU or EEA countries.
Each request is reviewed individually by our team of experts. Ideally, send us the instructions for use and your requirements and we will get back to you as soon as possible.
Yes, our network of laboratories and clinics spans several continents. We can organize the studies to comply with WHO standards and/or other country-specific standards.
Ellecom invests in the regulatory expertise of the team through regular internal and external regulatory trainings. We also offer training to you and design training for your employees according to your needs.
Elektronische Bauteile
Ellecom has three separate business units:
The Electronic Components division organizes the procurement of electronic components that are now discontinued products or end of life components (EOL).
The Medical Devices division specializes in the trade of, among other things, IVD products, products for wound care, and equipment and accessories for interventional cardiology and radiology.
The IvDV and MepV division offers regulatory solutions for manufacturers of in-vitro diagnostics and medical devices.
Ellecom specializes in the procurement of discontinued components. If an item has disappeared from the manufacturer’s range, we use our network of international suppliers to procure the obsolete product for you. To do this, we draw on worldwide inventories.
In cooperation with independent test houses, each product is tested for originality, quality and function. Only after successfully completed tests, the goods will be sent to you.
Ellecom takes care of the complete transportation of the products to the delivery address you specify. For shipping we cooperate with UPS and other forwarding and logistics companies.
The delivery time depends entirely on your wishes. However, please allow at least 10-12 business days from order to delivery.