1 HOUR FREE CONSULTANCY – Benelux Area

Regulatory Check Up

March 15th 2022

Since May 2021, the new EU Medical Devices Regulation ((EU) 2017/745 Regulation on medical devices (MDR)) has come into force, and from May 2022, the new EU In-vitro Diagnostics Regulation ((EU) 2017/746 Regulation on in-vitro diagnostic medical devices (IVDR)) will follow it.

 

This will be accompanied by far-reaching changes, including in the classification, clinical testing, and quality management of medical devices and in-vitro diagnostics.

 

With all these changes, we offer you an exclusive free check of your situation with regard to the new regulatory requirements.

 

Are all appointment options already taken? Please contact us at the following e-mail address to arrange additional appointments and options: pierre.geens@medidee.com

Benefit from an approximately one-hour personal exchange with experts on your topics such as:

  • Classification strategy of a complex hardware/software system
  • Clinical evaluation requirements of innovative orthopedic implants
  • Evaluation of your regulatory positioning
  • Evaluation of the impact of new European regulations (MDR & IVDR) on your strategy
  • Analysis and roadmap of needs for preclinical testing
  • Confirmation or building a safe plan including quality and clinical aspects.

How does it work?

Benelux-based medical device and in vitro diagnostic companies can sign up for one-hour free meeting. For targeted preparation, in order to generate as much added value as possible for you in the appointment, we ask you to provide the following information when registering:

  • Names of the participating persons
  • Name of the company
  • Specific topics/questions
  • In order to discuss your topics and questions with experts individually and in full confidentiality, no third party will be present during each appointment. Please let us know well in advance if you would like a non-disclosure agreement, which we will be happy to sign in advance.

 

Please select one of the remaining available appointment slots (possible slots: hourly from 8:30 a.m. to 4:30 p.m.; available when visible).

 

If you need a different appointment time than available or would like to change your appointment time, please feel free to contact us. We will then try to flexibly accommodate your request.