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ORPHAN MEDICAL DEVICES

YOUR TASK

For so-called orphan medical devices, comprehensive documentation must be prepared for classification as an orphan medical device. This documentation is required both for CE marking and during the entire time the product is placed on the market. This information should be included in all documents submitted to a Notified Body or an expert committee to determine the orphan device status.

YOUR CHALLENGES

We focus on meeting the specific requirements for your medical device.

Is your product classified as an orphan medical device?

 

How do you justify the orphan device status scientifically?

 

How do you take orphan device status into account in your clinical evaluation, in Risk Management and in the preparation of marketing material?

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What special features do you need to consider when planning PMS/PMCF for orphan devices?

 

How do you prepare the Structured Dialogue with your Notified Body for your orphan medical device?

 

Would you like to take advantage of the expert panel’s advice for your orphan medical device?

Our service

We carry out the scientifically sound classification as an orphan medical device for you and, if necessary, coordinate the consultation with the Notified Body or an expert committee. We also support you in preparing the Technical Documentation for CE marking and for the downstream PMS phase.

ORPHAN DEVICE CONSULTING AT A GLANCE

According to your needs - we respond to your individual requirements.

1

Projekt Kick-off

Together with you, we first work out your requirements for a successful project. A time frame is set in which the desired goals are to be achieved. The following points are then worked through as required.

2

Orphan device status

In order to successfully obtain CE marking as an orphan medical device, the orphan device status must first be clarified. To this end, we compile the epidemiology for you on a scientific basis and justify why your product should be classified as an orphan device. If your product is also used in other indications for non-orphan purposes, we limit ourselves to the orphan purpose or present the so-called orphan subpopulation.

3

Structured Dialogue

As orphan medical devices may be granted CE marking with limited clinical data, coordination with your Notified Body is essential.

We guide you through the process, prepare the Structured Dialogue, and accompany you during the discussions to ensure that they are successful.

4

Scientific Advice

An expert panel can give you advice on classification and clinical strategy. We prepare your documentation for presentation to an expert panel, help you with the application to the EMA and provide you with advice and support during the consultation.

5

Development of the regulatory strategy

Once orphan device status has been established beyond doubt, the regulatory and clinical strategy must be tailored to the special features of orphan medical devices. We pay particular attention to ensuring that the classification has a real benefit for you and does not turn out to be an additional hurdle.

6

Creation of Technical Documentation

The documentation for orphan medical devices includes aspects such as the justification of the classification, a focus on Risk Management, a product description with a section on the State of the Art, as well as a solid justification of the benefit-risk profile of the product and the acceptance to perform the conformity assessment with limited clinical data. These are collected in the clinical evaluation (CEP and CER). We then support you with targeted PMS/PMCF activities, for example to collect long-term safety and performance data. We ensure that all documents are submitted to the Notified Body in the required quality.

7

PMCF planning

Notified Bodies will tend to request PMCF studies or registries for orphan medical devices to fill the existing data gaps that existed prior to CE marking. Our PMCF experts will work with you to plan the most efficient measures.

8

Implementation of PMCF measures

In order to maintain the CE marking, PMCF measures imposed as a condition by the Notified Body may have to be implemented. The Notified Body must check the implementation. We support you in the implementation and thus ensure the long-term CE marking of your product.

Get in touch with our experts!

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Do you have any further requests?

Regular CER updates

Depending on the classification of the device, a regular update of the Clinical Evaluation is required: annually for implants and class III devices or every 1-5 years for other medical devices. We support you in efficiently updating your Clinical Evaluation documentation.

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PMCF

We describe the defined data sources and methods for the necessary activities. The existing interfaces within the Quality Management System are taken into account so that the measures can be carried out efficiently. All steps up to the creation of the reports are planned. Implementation of agreed activities:

- Searches in scientific databases and evaluation of the data to update the State of the Art
- Monitoring of the benefit/risk assessment together with the update of the Clinical Evaluation
- Supervision of PMCF studies, product registries and other PMCF measures

REQUEST

GAP Analysis

Before submitting your application to a Notified Body, let us perform a full GAP analysis of your Clinical Evaluation. We use an assessment template based on the MDCG 2020-13, as do the Notified Bodies.

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Training

Would you like to expand your expertise? Our training courses are delivered by our clinical and regulatory experts who aim to tailor the training to your needs, your product and your team's level of knowledge.

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