Regions
European Union
Our services enable non-EU manufacturers to access EU markets for Medical Devices, In Vitro Diagnostics, Cosmetics, and Personal Protective Equipment. We provide comprehensive support throughout the entire regulatory process, ensuring that your products meet all necessary EU standards and regulations. From initial application to final approval, our expert team assists you in navigating the complex regulatory landscape.
Medical Devices
To bring Medical Devices on the European Union market, manufacturers must comply with the MDR 2017/745. It determines that all non-EU manufacturers need to appoint a European Authorized Representative (EC-REP) when launching a Medical Device on the EU-market.
As your EC-REP, MedNet EC-REP, acts as the first contact person for local authorities. Our professionals ensure that you are always up-to-date according to the latest changes in EU regulations.
In Vitro Diagnostics
To sell In Vitro Diagnostics products on the EU market, manufacturers must comply with the IVDR 2017/746 which determines market access. In this case, you must have appointed a European Authorized Representative (EC-REP).
As your EC-REP partner in the field of In Vitro Diagnostics, MedNet provides all advisory and regulatory services to support you rolling out your products on the EU market.
Cosmetics
Manufacturers who want to place cosmetic products in the European Union must comply with the Cosmetics Regulation No. 1223/2009, which is determining access to EU markets for non-EU cosmetic products.
Therefore manufacturers need to appoint a Responsible Person to place cosmetics on the market. MedNet - as your Responsible Person - offers you all services and support to meeting the EU compliance requirements and to successfully place your products on the market.
Personal Protective Equipment
Roll outs of Personal Protective Equipments are regulated by the PPE Regulation (EU) 2016/425. It defines the access for PPEs to the European Union and forces manufacturers as you to appoint an European Authorized Representative (EC-REP) to place you solutions on the market.
As your representative partner MedNet acts as the initial contact to authorities, supports you navigating through the regulatory landscape of the Union and updates you in the latest changes of the regulations.
Get in Touch
Our cross-cultural team of scientists and engineers is well equipped to understand your needs.
Let us know your requirements and we will be at your service.
Frequently asked Questions
The Medical Device Regulation (MDR) is a comprehensive regulatory framework established by the European Union (EU) to ensure the safety, quality, and performance of medical devices. It replaces the previous Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD), aiming to enhance patient safety and streamline regulatory processes.
The primary objectives of the MDR include:
- Strengthening patient safety through stricter pre-market and post-market surveillance.
- Enhancing transparency and traceability of medical devices throughout their lifecycle.
- Promoting innovation and technological advancements while ensuring their safe and effective use.
- Improving coordination and collaboration among EU member states and regulatory authorities.
The MDR impacts various stakeholders involved in the medical device industry, including:
- Manufacturers of medical devices, including those producing software intended for medical purposes.
- Authorized representatives acting on behalf of manufacturers based outside the EU.
- Importers responsible for bringing medical devices into the EU market.
- Distributors involved in the supply chain of medical devices within the EU.
To ensure compliance with the MDR, companies should:
- Conduct a thorough review of their product portfolio to determine the classification and applicable requirements.
- Establish robust quality management systems (QMS) to meet the MDR's stringent regulatory standards.
- Compile comprehensive technical documentation, including clinical evaluation reports and risk management files.
- Implement post-market surveillance processes to monitor the safety and performance of medical devices.
- Collaborate closely with notified bodies and regulatory authorities to obtain necessary certifications.
The new Medical Device Regulation (MDR) 2017/745 and the In Vitro Diagnostic Regulation (IVDR) 2017/746 introduce more stringent requirements for medical devices and IVDs, including enhanced clinical evaluation, post-market surveillance, and traceability. These regulations require additional documentation and involve a higher level of scrutiny for all products. A significant change is the need for formal inclusion of the EC REP's