Regulatory Affairs

Regulatory Affairs

EMEA - Approval of Medical Devices worldwide

Successful approval of Medical Devices and IVDs worldwide

The CE mark not only is the basic prerequisite for placing a medical device on the european market, it can also be a chance for a registration of Medical Devices and IVD in further countries as well. Are you ready for the MDR and IVDR?

EMEA - Approval of medical devices worldwide

Successful approval of medical devices and IVDs worldwide

The CE mark not only is the basic prerequisite for placing a medical device on the european market, it can also be a chance for a registration of Medical Devices and IVD in further countries as well. Are you ready for the MDR and IVDR?

EMEA - Economic area Europe, Middle East and Africa

EMEA stands for Europe, Middle East and Africa and is an abbreviation for the economic area for the above mentioned regions. The focus here is on the home market of Europe, where the new Medical Device Regulation (MDR) has opened a new chapter in the Medical Device industry; with significant requirements for Medical Devices and their conformity assessment. But the solvent countries in the Middle East or in Africa such as:

  • Saudi Arabia
  • United Arab Emirates
  • Israel
  • Egypt

are also interesting markets for the export of Medical Devices.

Conformity assessment of Medical Devices in Europe – Medical Device Regulation (MDR) & In Vitro Diagnostic Regulation (IVDR)

The new European Medical Device Regulation (EU) 2017/745 now composes the requirements for the conformity assessment of Medical Devices. It combines and replaces the previously independent directives for Medical Devices (MDD) and Active Implantable Medical Devices (AIMD). With the postponement of 1 year caused by COVID-19, the new date of validity of the MDR is 26 May 2021.

The requirements for the conformity assessment procedure of in vitro diagnostics are laid down in the separate IVD regulation (EU) 2017/746.

European Union and yet no unity?

Even with the implementation of the MDR and IVDR, national requirements are still established, and differentiate from country to country. By application of the CE mark, you can theoretically sell your Medical Device throughout Europe. But is the German and English user documentation sufficient for that?

Further possible obstacles in Europe are:

  • Special cases like Switzerland or the UK
  • Changing circumstances due to COVID-19
  • Common specifications defined by the European Commission
  • Notified Bodies who are insecure about the interpretation of the requirements

qtec as your partner

We will guide you through complex requirements in individual European countries, with the implementation of the EU MDR. Additionally, in case of difficulties and or disagreements with your Notified Body our experts are eager to help.

Our specialists are always up to date, know the most recent requirements and can implement these requirements focused and compliant to your needs. Whether generic questions or specific topics like biocompatibility and UDI, our team has the answer.

 

Our expert knowledge for your success

We have in-depth, worldwide expertise in the Approval and registration of Medical Devices. I will answer your questions about the MDR and put together a team for your project upon request.

Contact +49 451 808 503 60

Approval of Medical Devices in the Middle East and Africa

In many countries in the Middle East and Africa, the CE mark is sufficient to place Medical Devices on the market. But slowly more and more countries are creating their own regulations based on European and American laws.

Do you know which powerful importing country in the Middle East will be the first to introduce a UDI in this area?

We can also assist you with market access in Africa and the Middle East, such as Saudi Arabia, which is the first country in the Middle East to introduce a UDI based on American and European models.

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