ECLEVAR MedTech Germany clinical trial cro

ECLEVAR Germany extends this support to the German market, ensuring compliance with both current and new regulatory frameworks.

We offer customizable market access strategies globally and locally, helping you identify the necessary evidence to successfully launch your product.

Streamlined Support for Medical Device Market Access

ECLEVAR MEDTECH is a global Contract Research Organization (CRO) headquartered in France. We assist medical device and in vitro diagnostic (IVD) manufacturers in transitioning to the EU Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (EU IVDR).

Our services include clinical evaluation, pre-market clinical trials, Post-Market Clinical Follow-up (PMCF) studies, and leveraging real-world data (RWD) and real-world evidence (RWE) for regulatory submissions.

Our Clinical Trial Services

Market Access Strategies

Clinical Evaluation Reports

First-in-Human Clinical Trials

Registries

Observational Studies

Surveys

CE Marking – What Are the Requirements?

To place a medical device on the market in Germany, a CE mark is required. Manufacturers must comply with the following regulations:

Regulation (EU) 2017/745 on medical devices (EU MDR)
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (EU IVDR)

These regulations have replaced the previous European directives:

Directive 90/385/EEC on active implantable medical devices (EU AIMDD)
Directive 93/42/EEC on medical devices (EU MDD)
Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD)

What Do You Need to Do?

Determine Your Product Classification

This will influence the regulatory pathway required to access the market.

Ensure Compliance

Adhere to all applicable requirements of the EU MDR or EU IVDR for your product.

Register Your Device

All medical devices and IVDs must be registered with the German competent authorities, such as the Federal Institute for Drugs and Medical Devices (BfArM) or the Paul-Ehrlich-Institut (PEI).

Appoint an EU Authorized Representative

If you are a manufacturer based outside the EU, you must designate an Authorized Representative within the EU. The name and address of the Authorized Representative must be included on the product labeling, outer packaging, or instructions for use.

What Is ECLEVAR Germany Doing to Prepare for the New Regulations?

ECLEVAR Germany is an active member of major industry associations in Germany. We collaborate with their regulatory groups to support ongoing work on new regulations and ensure we are informed of key updates on their progress.

We are closely monitoring legislation and guidance to inform our clients about current and future requirements. We understand that there is significant alignment with the EU MDR and EU IVDR, with some Germany-specific policies aiming to make the country an attractive place to develop and market medical devices and IVDs.

Within 3 years, ECLEVAR delivered transformative solutions in Clinical Trial

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