Knowledge Center

At Med-Di-Dia, we offer tailored services to assist health institutions in navigating the complex regulatory landscape for in-house manufacturing of medical devices (MDs) and in vitro diagnostic medical devices (IVDs). With our deep expertise in EU regulations and compliance, we ensure that your institution meets all the legal requirements while streamlining the notification process with the Health Products Regulatory Authority (HPRA).

Our Key Services Include:

1. Regulatory Guidance and Compliance
   We provide comprehensive guidance to ensure your health institution complies with all relevant regulations, including:
   • Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
   • Regulation (EU) 2017/745 on medical devices (MDR)
   • S.I. No. 691/2021 Medical Devices (Registration) Regulations
   • S.I. No. 365/2022 In Vitro Diagnostic Medical Devices (Registration) Regulations
2. HPRA Notification Process Support
   Our team will help you complete and submit the required HPRA in-house manufacture notification forms, ensuring all fields are correctly filled out , and all necessary documentation is provided. This includes:
   • Health institution details
   • Public declaration URLs
   • Contact point and governance coordination
   • Acceptance of terms and conditions
3. Public Declaration Assistance
   We assist institutions in creating compliant public declarations for in-house manufactured MDs and IVDs, as required under Article 5(5e) of MDR and Article 5(5f) of IVDR. This service is crucial for maintaining transparency and trust with your stakeholders. If your health institution lacks this information on its website, we can guide you in developing and publishing it.
4. Coordination with Laboratories and Departments
   We help identify the correct points of contact for in-house manufacturing notifications to ensure seamless communication between your laboratories and departments. This service plays a vital role in maintaining the efficiency and effectiveness of your operations. We also coordinate with your teams to ensure governance structures are informed and regulatory requirements are met.
5. Ongoing Regulatory Support
   As regulations evolve, so do your obligations. Our ongoing support services ensure that your institution remains compliant with the latest requirements, including notifying the HPRA of any substantial changes to your in-house manufacturing processes or contact details.
6. Documentation Review and Submission
   We assist in reviewing all necessary documentation for MDs and IVDs, such as:
   • Declaration of Conformity
   • Labelling and instructions for use
   • Technical documentation (as per MDR/IVDR requirements)
7. Inspection Preparation and Compliance Audits
   In the event of HPRA inspections or checks, we help you prepare by conducting internal audits and providing guidance on compliance with Article 5(5) of MDR and IVDR. Our team ensures your processes and documentation are ready for review by competent authorities.

Why Choose Med-Di-Dia?

• Expertise in EU Regulations: With in-depth knowledge of MDR and IVDR, we ensure your institution is always compliant.
• Tailored Services: Our support is customised to meet the unique needs of your institution, whether you manufacture in-house MDs, IVDs, or both.
• End-to-End Support: From initial notification to ongoing compliance, we handle the entire regulatory process, allowing you to focus on patient care.

For more information or to get started with our services, contact us at mdd@mddltd.com or submit a webform - https://med-di-dia.com/contact.php. Let us be your partner in regulatory compliance and ensure your institution's in-house medical devices are fully compliant with HPRA requirements.