Digital(AI), In-vitro & Medical Devices

The European Commission is conducting a comprehensive evaluation of the Medical Device Regulation (MDR – EU 2017/745) and In Vitro Diagnostic Regulation (IVDR – EU 2017/746) to assess their effectiveness, challenges, and impact on innovation, patient access, and regulatory capacity.

Purpose of the Evaluation: Identify bottlenecks in implementation, assess administrative burden on manufacturers and notified bodies, examine the regulatory impact on small and medium-sized enterprises (SMEs), and the availability of devices

Final Evaluation Report Due: Q4 2025

What This Means for You:
Manufacturers of medical devices, IVDs, and combination products should anticipate potential regulatory changes or new guidance starting late 2025 or early 2026 and monitor closely for the final report release in Q4 2025.

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Vital Steps in the EU Regulatory Procedure

Please reach us at hello@indaea.co if you cannot find an answer to your question.

Step 1 - Device Classification

Classify the device under MDR: Class I (low risk), Class IIa, Class IIb, or Class III (highest risk).

Classification determines the regulatory pathway and involvement of a Notified Body.

Key: Classification depends on intended use, invasiveness, duration of contact with the body, and other factors.

Step 2 - QMS Establishment

Implement and maintain a Quality Management System (QMS), usually aligned with ISO 13485.

Required for all classes, especially when a Notified Body assessment is needed.

Step 3 - EAR Appointment

Non-EU manufacturers must designate an EU Authorized Representative (EAR) based in the EU.

The representative acts on your behalf regarding compliance obligations.

Step 4 - Clinical Evaluation

Provide clinical evidence supporting device safety and performance. Options:

Literature review (for similar devices).
Clinical investigation (especially for novel Class III or implantables).

Step 5 - Technical File Creation

Must demonstrate safety, performance, and compliance with General Safety and Performance Requirements (GSPR). Includes:

Product description and specification.
Risk management file (ISO 14971 compliant).
Clinical evaluation report.
Post-market surveillance plan.
Labeling and Instructions for Use (IFU).

Step 6 - CAP and CE Mark

Higher-risk devices require:

Conformity Assessment Procedure (CAP) by a designated Notified Body (NB).
Review of your QMS and technical documentation.

Leads to receiving a CE Certificate (not needed for most Class I devices).

Step 7 - EUDAMED registration

European Database on Medical Devices (EUDAMED) registration includes:

Actor registration (manufacturer/Authorized Representative).
Device registration in the Unique Device Identifier (UDI) registration module.

Some modules are still rolling out.

Step 8 - Vigilance and PMS

Maintain active Post-Market Surveillance (PMS) activities.

Conduct Periodic Safety Update Reports (PSURs) for certain device classes.

Report serious incidents and Field Safety Corrective Actions (FSCAs) to authorities.

EU Medical Devices Regulation (MDR)

EU In Vitro Diagnostics Regulation (IVDR)

Regulates products, services, or solutions that prevent, diagnose, monitor, treat, and care for people.

Regulation EC 745/2017

EU In Vitro Diagnostics Regulation (IVDR)

Regulates non-invasive tests used on biological samples (for example, blood, urine, or tissues) to determine the status of a person’s health.

Regulation EC 746/2017

EU AI Act

EU In Vitro Diagnostics Regulation (IVDR)

FDA 21 CFR Chapter I, subchapter H - MDs

Regulation (EU) 2024/1689 of the European Parliament laying down harmonized rules on artificial intelligence and amending other relevant regulations.

Regulation EC 1689/2024

FDA 21 CFR Chapter I, subchapter H - MDs

FDA Medical Devices Quality System Regulation

FDA 21 CFR Chapter I, subchapter H - MDs

In 1982, the US FDA that regulated medical devices and radiation-emitting products merged to form the Center for Devices and Radiological Health (CDRH).

21 FDA CFR 800 - 898

FDA Medical Devices Quality System Regulation

Quality policy. Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization.

21 CFR 820

UK Medical Devices Regulation

FDA Medical Devices Quality System Regulation

The agreement on mutual recognition concerning conformity assessment certificates and markings, MHRA has with the EU, US, Canada, TGA & New Zealand.

UK MDR 2002 No. 618

ISO 13485:2016 Medical devices QMS - Regulatory purposes

Medical devices — Quality management systems — Requirements for regulatory purposes

ISO 13485:2016

ISO 9001:2015 QMS Requirements

ISO 13485:2016 Medical devices QMS - Regulatory purposes

Quality management systems – Requirements

ISO 9001:2015

Medical Devices Single Audit Program (MDSAP)

ISO 13485:2016 Medical devices QMS - Regulatory purposes

Medical Devices Single Audit Program (MDSAP)

The Medical Device Single Audit Program allows to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.

MDSAP

ISO 10993-1:2018, Biological evaluation of medical devices

ISO 11607-1:2019 Packaging for terminally sterilized medical devices

ISO 11137-1:2006 Sterilization of health care products - Radiation

Part 1: Evaluation and testing within a risk management process.

ISO 10993-1:2018

ISO 11137-1:2006 Sterilization of health care products - Radiation

ISO 11607-1:2019 Packaging for terminally sterilized medical devices

ISO 11137-1:2006 Sterilization of health care products - Radiation

Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices.

ISO 11137-1:2006

ISO 11607-1:2019 Packaging for terminally sterilized medical devices

Part 1: Requirements for materials, sterile barrier systems, and packaging systems.

ISO 11607-1:2019

ISO 14644:2015 Cleanrooms, and associated controlled environments

ISO 11607-1:2019 Packaging for terminally sterilized medical devices

Part 1: Classification of air cleanliness by particle concentration

Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration

ISO 14644:2015

ISO 14937:2009 Sterilization of health care products

ISO 14644:2015 Cleanrooms, and associated controlled environments

ISO 14937:2009 Sterilization of health care products

General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

ISO 14937:2009

ISO 14971:2019 Risk Management

ISO 14644:2015 Cleanrooms, and associated controlled environments

ISO 14937:2009 Sterilization of health care products

Application of risk management to medical devices.

ISO 14971:2019

ISO 15223-1:2021 Labelling

IEC 62304:2006/ Amd1:2015 SaaMD

ISO 15223-1:2021 Labelling

Symbols to be used with medical device labels, labeling and information to be supplied - Part 1: General requirements.

ISO 15223-1:2021

ISO/IEC 17025:2017 Testing

IEC 62304:2006/ Amd1:2015 SaaMD

ISO 15223-1:2021 Labelling

General requirements for the competence of testing and calibration laboratories.

ISO/IEC 17025:2017

IEC 62304:2006/ Amd1:2015 SaaMD

IEC 62366-1:2015 Engineering to MDs

Medical device software, software life cycle processes.

IEC 62304:2006/Amd1:2015

IEC 62366-1:2015 Engineering to MDs

Application of usability engineering to medical devices

IEC 62366-1:2015

Digital(AI), In-vitro & Medical Devices

Sector Overview

Top 5 Industry Trends

Vital Steps in the EU Regulatory Procedure

EU Medical Devices Regulation (MDR)

EU In Vitro Diagnostics Regulation (IVDR)

EU In Vitro Diagnostics Regulation (IVDR)

EU In Vitro Diagnostics Regulation (IVDR)

EU In Vitro Diagnostics Regulation (IVDR)

EU In Vitro Diagnostics Regulation (IVDR)

EU AI Act

EU In Vitro Diagnostics Regulation (IVDR)

FDA 21 CFR Chapter I, subchapter H - MDs

FDA 21 CFR Chapter I, subchapter H - MDs

FDA Medical Devices Quality System Regulation

FDA 21 CFR Chapter I, subchapter H - MDs

FDA Medical Devices Quality System Regulation

FDA Medical Devices Quality System Regulation

FDA Medical Devices Quality System Regulation

UK Medical Devices Regulation

FDA Medical Devices Quality System Regulation

FDA Medical Devices Quality System Regulation

ISO 13485:2016 Medical devices QMS - Regulatory purposes

ISO 13485:2016 Medical devices QMS - Regulatory purposes

ISO 13485:2016 Medical devices QMS - Regulatory purposes

ISO 9001:2015 QMS Requirements

ISO 13485:2016 Medical devices QMS - Regulatory purposes

ISO 13485:2016 Medical devices QMS - Regulatory purposes

Medical Devices Single Audit Program (MDSAP)

ISO 13485:2016 Medical devices QMS - Regulatory purposes

Medical Devices Single Audit Program (MDSAP)

ISO 10993-1:2018, Biological evaluation of medical devices

ISO 11607-1:2019 Packaging for terminally sterilized medical devices

ISO 11137-1:2006 Sterilization of health care products - Radiation

ISO 11137-1:2006 Sterilization of health care products - Radiation

ISO 11607-1:2019 Packaging for terminally sterilized medical devices

ISO 11137-1:2006 Sterilization of health care products - Radiation

ISO 11607-1:2019 Packaging for terminally sterilized medical devices

ISO 11607-1:2019 Packaging for terminally sterilized medical devices

ISO 11607-1:2019 Packaging for terminally sterilized medical devices

ISO 14644:2015 Cleanrooms, and associated controlled environments

ISO 14644:2015 Cleanrooms, and associated controlled environments

ISO 11607-1:2019 Packaging for terminally sterilized medical devices

ISO 14937:2009 Sterilization of health care products

ISO 14644:2015 Cleanrooms, and associated controlled environments

ISO 14937:2009 Sterilization of health care products

ISO 14971:2019 Risk Management

ISO 14644:2015 Cleanrooms, and associated controlled environments

ISO 14937:2009 Sterilization of health care products

ISO 15223-1:2021 Labelling

IEC 62304:2006/ Amd1:2015 SaaMD

ISO 15223-1:2021 Labelling

ISO/IEC 17025:2017 Testing

IEC 62304:2006/ Amd1:2015 SaaMD

ISO 15223-1:2021 Labelling

IEC 62304:2006/ Amd1:2015 SaaMD

IEC 62304:2006/ Amd1:2015 SaaMD

IEC 62366-1:2015 Engineering to MDs

IEC 62366-1:2015 Engineering to MDs

IEC 62366-1:2015 Engineering to MDs

IEC 62366-1:2015 Engineering to MDs

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