Technical Documentation for EU MDR and IVDR Compliance
Ensure full EU MDR and IVDR compliance for your medical device or IVD with our comprehensive Technical Documentation File preparation services.
Essential Technical Documentation for EU MDR & IVDR Compliance
The Technical Documentation File serves as the basis for your Declaration of Conformity and CE Marking under the MDR or IVDR, which is required for placing a medical device or IVD on the European market. Preparing your Technical Documentation File for your medical device or IVD requires substantial resources and deep understanding of the requirements for your product. Get it wrong and you may have to backtrack, which could cost you even more time and money. Even if you have regulatory capability in-house, they may not have the bandwidth to complete this essential step.
MedEnvoy specializes in Technical Documentation File preparation to the EU MDR and IVDR. Our team of regulatory consultants and project managers are accessible and responsive, with expertise to efficiently compile your Technical Documentation File.
We offer two levels of support to meet your needs:
- Templates and Consulting Support
- Turnkey Consulting Support
EU MDR/IVDR Documentation Templates & Consulting Support
Leverage our expertise to compile your MDR or IVDR technical documentation in house. We provide the templates you need to meet the applicable requirements, including:
- Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) or Performance Evaluation Plan (PEP) and Performance Evaluation Report (PER).
- General Safety and Performance Requirements checklist.
- Risk Assessment and Risk Management Plan to ISO 14971.
- Post Market-Surveillance (PMS) Plan and Report.
Our templates come with 10 hours of guidance from our team of experts. We’ll walk you through how to customize each template. We also explain how to implement required methodologies and procedures, such as how to conduct a risk analysis and implement a risk management process according to ISO 14971. This option is ideal for manufacturers with in-house resources who want a running start.
Turnkey EU MDR / IVDR CE Marking Consulting Support
Put the full weight of our experienced team behind your CE Marking efforts. We’ll handpick a team for your project, including a lead consultant and project manager. From there, we manage all aspects of your EU MDR or IVDR compliance, including evaluating your documentation and labeling, developing templates and procedures, and compiling all the documentation you need to complete your Technical Documentation File.
How we help:
- Quality Management System (QMS) compliance consulting.
- Full gap assessment of current technical documentation to MDR or IVDR.
- Technical Documentation File preparation and compilation in preparation for Notified Body submission.
- CEP and CER compilation for medical devices or Performance Evaluation Plan (PEP) and Performance Evaluation Report (PER) for IVDs,as well as draft procedures for maintaining your CER and Post-Market Clinical Follow-up (PMCF).
- Risk Assessment and Management (ISO 14971).
- Labeling, packaging, and Instructions for Use (IFU) review to applicable standards.
- UDI application consulting.
- Authorized Representation (if required).
Our full-service option takes you all the way to the finish line. Let us be your single point-of-contact for all your medical device and IVD regulatory needs in Europe.
