We respond to all your requests
according to the EU regulations
to MDR and IVDR
We help to implement 7
different ISO standards
Regulatory & Compliance
Advice on regulatory requirements
Solutions for Procurement & Regulatory Affairs
With its three business units Regulatory, Medical Devices and Electronic Components, Ellecom is a strategic partner for customers from a wide range of industries. Our international team with high competence for regulatory topics as well as procurement and trade advises and supports you expertly and routinely.
You have questions?
Search your answers here
Medical & Regulatory
Any product that has been certified under MDD or IVDD will need to be re-tested under MDR / IVDR. The timeframe depends on when you received MDD / IVDD certification.
We recommend starting with a gap analysis and reviewing your current documentation. Our team of MDR and IVDR experts will help you develop a compliance and regulatory strategy and implement it successfully.
Studies with the aim of obtaining CE marking are performed in European laboratories and with European samples.
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.
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.
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.
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.
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 IVDR and MDR area 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.