What is Technical Documentation?
The technical documentation of a medical device is a set of documents that contains all the necessary information to demonstrate the safety, effectiveness, and compliance of the device with the requirements of European regulations (MDR 2017/745 and IVDR 2017/746).
What is it for?
Demonstrates that the device meets the essential safety and performance requirements;
It is mandatory for CE marking, allowing commercialization in the European Union;
It must always be up to date and available to competent authorities.
What should it include?
The content may vary depending on the device’s risk class but generally includes:
Device description;
Device classification (justification according to the MDR/IVDR rules);
Compliance with general safety and performance requirements;
Product verification and validation;
Benefit-risk analysis and risk management;
Traceability and UDI;
Instructions for use;
Manufacturing process;
Post-market surveillance.
What is CE Marking?
The CE Marking is a mandatory certification indicating that a product complies with the essential safety, health, and performance requirements established by the European Union.
What does it mean?
It allows the product to be marketed and used in the European Economic Area (EEA);
Ensures that the product meets applicable European standards and regulations;
For medical devices, CE Marking is mandatory and regulated by MDR 2017/745 and IVDR 2017/746.
How to obtain CE Marking for Medical Devices?
The process varies depending on the device's risk class and may include:
Device Classification – Determining the class (I, IIa, IIb, or III) according to MDR.
Technical File Preparation – Creating documentation that proves the device’s compliance.
Conformity Assessment – May involve a Notified Body (for higher-risk devices).
Implementation of a Quality Management System – Example: ISO 13485.
Testing and Clinical Trials – If necessary, to prove safety and efficacy.
Declaration of Conformity for Class I (sterile or with a measuring function), IIa, IIb, and III devices, and Self-Declaration of Conformity for Class I devices (except those that are sterile or have a measuring function).
CE Marking Placement – The product can be marketed in the European market.
What is EUDAMED?
EUDAMED (European Database on Medical Devices) is a system created by the European Union to improve transparency and market surveillance of medical devices. It is part of the Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Medical Device Regulation (IVDR 2017/746).
The main functions of EUDAMED are:
Registering medical devices, manufacturers, authorized representatives, and importers;
Ensuring traceability and compliance of devices on the market;
Facilitating access to information for regulatory authorities and users;
Improving patient safety through greater transparency.
What is the Person Responsible for Regulatory Compliance (PRRC)?
The Person Responsible for Regulatory Compliance (PRRC) is a mandatory role for manufacturers and authorized representatives of medical devices in the European Union, according to the MDR 2017/745 and IVDR 2017/746 regulations.
What does the PRRC do?
The PRRC is responsible for ensuring the manufacturer complies with regulatory requirements, including:
Verifying device compliance before marketing;
Maintaining technical documentation and the declaration of conformity;
Managing post-market surveillance and reporting incidents;
Ensuring manufacturing compliance with quality requirements.
What is the European Authorized Representative (EC REP)?
The European Authorized Representative (EC REP) is a legally designated entity by medical device manufacturers outside the European Union (EU) to ensure regulatory compliance and act as a contact point with European authorities.
Responsibilities of the EC REP:
Ensuring regulatory compliance of the device before marketing in the EU;
Maintaining technical documentation and the Declaration of Conformity available for authorities;
Cooperating with national authorities during audits and investigations;
Managing incident notifications and corrective actions related to post-market surveillance;
Including the name and address on the device packaging for clear identification in the European market.
What is the UDI?
The UDI (Unique Device Identification) is a mandatory global identification system for medical devices in the European Union, according to MDR 2017/745 and IVDR 2017/746 regulations. The goal is to improve traceability, safety, and transparency of medical devices on the market.
UDI Elements:
The UDI consists of two main codes:
UDI-DI (Device Identifier) – Identifies the specific model of the device and is fixed.
UDI-PI (Production Identifier) – Contains variable information, such as batch number, serial number, and expiration date.
What is the importance of UDI?
Facilitates traceability and recall management;
Enhances patient safety and reduces medical errors;
Helps combat counterfeiting and quality control.
What is a Notified Body (NB)?
Notified Bodies (NB) are independent entities designated by the European Union to assess the compliance of medical devices and in vitro diagnostic medical devices (IVD), according to MDR 2017/745 and IVDR 2017/746 regulations.
Who needs a Notified Body?
Submission to an NB is mandatory for higher-risk medical devices, i.e.:
MDR 2017/745:
✅ Class IIa
✅ Class IIb
✅ Class III
🚫 Class I (except for sterile devices, measuring devices, or reusable devices – in these cases, an NB is required).
IVDR 2017/746:
✅ Classes B, C, and D (mandatory)
🚫 Class A (except for sterile devices).
What is the importance of an NB?
Access to the EU market – Devices without NB certification (when required) cannot be marketed;
Safety and compliance – The process ensures devices meet safety and performance standards;
Credibility and international acceptance – Certifications issued by NBs are widely recognized in the industry.
Is certification of ISO 13485 and ISO 14971 mandatory?
Certification is not mandatory, only implementation is required. However, certification greatly helps demonstrate compliance when evidence is requested.
