Services for MDR and IVDR

Regulatory compliance and market access

Market access for medical devices depends on the safety and performance of a medical product. The comprehensive regulatory framework is an EU tool to ensure greater transparency in the medical device sector, but more importantly to increase patient safety and bring clarity to the processes around medical device approval for all stakeholders.

From a manufacturer's perspective, balancing continuous innovation with regulatory requirements is key to consistency and growth.
The introduction of the new Medical Device Regulation (MDR) and the In-vitro Diagnostic Devices Regulation (IVDR) has changed the European medical device market enormously.
This affects all players involved, but especially manufacturers of medical devices and in vitro diagnostics, both on a national and global level.

Ellecom has expertise and competence in meeting challenging regulatory requirements in an international context. We are a leading partner in the execution and follow-up of regulatory and technical documentation. Thus, we enable maximum efficiency in product registration.

Regulatory Affairs

Registration with EUDAMED, EU-IVDR and CE registration, EU-MDR and CE registration, gap analysis, PRRC, regulatory strategy consulting.

Clinical affairs

CRO services, clinical evaluation (MDR), performance evaluation (IVDR).

Technical Documentation

Post Market Surveillance System, Technical File Support, Labelling Compliance.

Market Access

Representative Services, i.e. EU-Rep Services and Swiss-Rep Services as well as USA FDA and China NMPA and India ICMR Market Access Services.

Quality Standards

ISO Standards - we help with implementation of seven different ISO standards.


EU IVDR Compliance, EU MDR Compliance, Clinical Evaluation.

We support you step by step.

1. Gap Analysis - We check your documents and your quality system.
2. Classification of the Medical Device - We support you in the correct classification of your medical device.
3. Validation and Preparation of Applications - According to the legal requirements of the EU, Switzerland, or the further target country we support you in the preparation of the submission documents.
4. Submission of Documents and Registration - For the EU, Switzerland as well as further international markets we carry out the registration procedure with you and for you.
5. Successful Market Approval - With the confirmation by the responsible authorities, the way is open for successful sales and distribution.
What are medical devices? compliance & regulatory

A medical device is an instrument, apparatus, device, machine, appliance, implant, reagent for in vitro use, software, material, or similar or related item intended by the manufacturer to be used alone or in combination for a medical purpose.  

What are IVD (in vitro diagnostic) products?

Diagnosis is the first step to effective treatment and the first protection against the spread of many diseases. In vitro diagnostics are clinical tests that analyze samples taken from the human body. They help cure, treat or prevent diseases.

These tests include laboratory-based tests, in which samples are sent to a central laboratory for analysis, point-of-care tests, which can be performed near or at the site of patient care, and tests that consumers can use at home.

Ellecom works with an experienced team dedicated to compliance and regulatory issues in the MDR market and the IVD market, and always keeps abreast of new trends and requirements in the medical device and IVD market.

The changing regulatory framework created by the implementation of the EU Medical Devices Regulation (2017/745) and the EU In Vitro Medical Devices Regulation (2017/746) is impacting how medical devices and IVDs are reclassified and, if necessary, upscaled.

Companies with knowledge and experience of regulatory issues will find it easier to ensure a smooth transition.

Over the years, Ellecom has established sustainable business relationships with various competent authorities, notified bodies, clinical laboratories and think tanks. The company is also working on a dynamic, evolving and efficient post-market surveillance system. The knowledge and network-based methodology provide Ellecom with a competitive advantage in the market and the ability to serve the price-sensitive medical device and IVD market.

Since its inception, Ellecom has worked with manufacturers specializing in the production of in vitro diagnostics and other medical devices and understands the market for these products. Ellecom, with its product and regulatory knowledge and experience, provides its customers with services related to the mandatory requirements needed to place goods on the European market for the first time, such as clinical validations, CE certifications, product registrations, etc. In addition to the legal and regulatory requirements, it also offers customized services to its customers.

How can we support you?

Please contact us and one of our team members will get in touch with you.