Navigating the complexities of European Union Medical Device Regulation (EU MDR 2017/745) can be challenging for manufacturers aiming to affix the CE mark to their products.

At EPINTEK, we provide comprehensive and tailored CE certification services to ensure your medical devices meet all necessary EU requirements, facilitating seamless market entry across the European Economic Area (EEA).

Understanding EU MDR and CE certification

Since May 2021, medical device manufacturers must comply with the EU MDR rather than the previous Medical Device Directive (93/42/EEC). This regulation classifies devices into four categories based on risk level: Class I, IIa, IIb, and III. The classification determines the conformity assessment route and the involvement of a Notified Body.

Comprehensive Services for All Classes of Medical Devices

At EPINTEK, we offer specialized support for each category:

Class I Medical Devices: For low-risk devices, our service includes self-certification guidance. If your product is sterile or has measuring functions, we assist in obtaining certification through a Notified Body.

Class IIa Medical Devices: These medium-low risk devices, such as surgical gloves or hearing aids, often require Notified Body assessments. We guide you through selecting the appropriate conformity assessment module and preparing for evaluations.

Class IIb Medical Devices: For medium-high risk devices like long-term corrective contact lenses or defibrillators, extensive documentation and Notified Body involvement are necessary. Our team ensures your technical files align perfectly with EU MDR requirements.

Class III Medical Devices: High-risk devices including cardiovascular stents or hip implants need rigorous monitoring throughout their lifecycle. We help manage these stringent requirements, ensuring continuous compliance and safety.

Essential Steps for CE Certification

Our process covers every crucial step from start to finish:

 Confirm Export Country: Ensure your device requires CE certification for any of the 30 EEA member states.

 Classification and Directives: Accurately classify your device according to EU directives and identify applicable standards.

 Appoint an EU Authorized Representative: We assist in designating a representative within the EU to handle regulatory communications and ensure ongoing compliance.

 Select Appropriate Conformity Assessment Module: Choose from nine basic modules ranging from internal production control (Module A) to full quality assurance (Module H), depending on your device's risk level.

 Establish and Maintain Technical Files: Our experts help compile detailed technical documentation that complies with EU MDR, keeping it updated as needed.

Why Choose EPINTEK?

With over 1200 Notified Bodies available for various types of certifications, choosing the right partner is critical. EPINTECH stands out by offering:

 - Expert Guidance: From initial classification to final certification, we provide unparalleled expertise.

 - Custom Solutions: Tailored strategies for different device classes and regulatory pathways.

 - Streamlined Process: Efficient handling of documentation, testing, and certification processes.

 - Ongoing Support: Continuous assistance in maintaining compliance and updating technical files.

Trust EPINTEK to navigate the intricate path of EU MDR compliance and CE certification. Let us empower your medical devices to reach the vast European market efficiently and confidently. With EPINTEK your journey from concept to CE certification becomes smoother, faster, and more assured.

For more information about our services or to tailor specific solutions, please contact our professional team.