Introduction to EU Medical Devices Regulation 2017/745 (MDR) Training Course

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Since the inception of the EU Medical Device Regulations, selling Medical devices in Europe has become a topical discussion with much debate and discretion, manufacturers selling Medical Devices in Europe have been encouraged by the EU Parliament to continue implementing the EU MDR and transitioning from the Medical Device Directive. In this course, you shall learn what is required to implement the EU MDR using the appropriate articles and annexes from the regulation.

In this course, you will learn:

  1. The differences between Medical Device Directives and the Medical Device Regulations
  2. What you need to do in your Regulatory Strategy
  3. What you need to change in your QMS to Article 120
  4. What you need to do according to Article 10a Obligations of Manufacturers
  5. According to Articles 61- 66 Clinical Evaluation and Annex XIV
  6. Your Test strategy to validate your device
  7. Creation of a Technical File to Annex II
  8. What to write in your Declaration of Conformity
  9. How to write your GSPRs to Annex I
  10. What you need to do as a Class I, IIa, IIb and Class III Medical Device.
  11. Submitting a Technical File to a Notified Body
  12. What to expect from your audit
  13. EUDAMED and Authorised Representative
  14. Post Market Surveillance, and Periodic Safety Update Report.

Course Duration: 0.5 to 2 days

Module 1: Introduction to EU Medical Device Regulations & Implementing a QMS according to EU MDR Regulations & What you need to change in your QMS to Article 120

The differences between Medical Device Directives and the Medical Device Regulations. What you need to do in your Regulatory Strategy. What Articles and Annexes to quote and in which procedures within your ISO 13485 QMS?

Module 2: What you need to do according to Article 10a Obligations of Manufacturers

In this part, we discuss as a legal manufacturer what obligations you must fulfil according to the EU MDR.

Module 3: According to Articles 61- 66 Clinical Evaluation and Annex XIV

Clinical Evaluations are known to be a big area of contention, so making equivalence is not so easy. What do you need to do to ensure your device conforms to the EU MDR requirements for equivalency and what you can do to avoid performing Clinical Investigations and remaining compliant? We will also discuss Clinical Investigations should you not be able to claim equivalence according to ISO 14155.

Module 4: Your Test strategy to validate your device

We will discuss the intended Use Statement, User Requirements, Design Inputs, Outputs and Testing Verification and Validation to demonstrate a trace of the design. This includes the Design Development Plan, Design Review meetings and Design Freeze.

Module 5: Creation of a Technical File to Annex II

We will talk you through the creation of a CE Technical File according to the requirements of Annex II of the EU MDR 2017/745. This part includes what to write in your Declaration of Conformity and also how to write your GSPRs to Annex I.

Module 6: What you need to do as a Class I, IIa, IIb and Class III Medical Device.

Writing a Technical File is challenging but even more so if the Classification of your device is a Class IIb or Class III, in this lesson we shall discuss what you need before submitting a Technical File to a Notified Body and then what to expect from your audit.

Module 7: EUDAMED and Authorised Representative and Economic Operators & Post Market Surveillance, and Periodic Safety Update Report.

We shall discuss your responsibility as an actor according to EU law and the EUDAMED database as well as appointing an Authorised Representative. We shall also look at PMS activities. We will also look at the role of Economic Operators, that is the Manufacturer, Importer and Distributor in addition to the Authorised Representative.

The benefit of this course is that you will be more confident about the entire process of CE marking a Medical Device to commercialise your device in the EU market. Having a CE marked device opens up doors in other territories in addition to EU.

In this course, you will learn:

  1. The differences between Medical Device Directives and the Medical Device Regulations
  2. What you need to do in your Regulatory Strategy
  3. What you need to change in your QMS to Article 120
  4. What you need to do according to Article 10a Obligations of Manufacturers
  5. According to Articles 61- 66 Clinical Evaluation and Annex XIV
  6. Your Test strategy to validate your device
  7. Creation of a Technical File to Annex II
  8. What to write in your Declaration of Conformity
  9. How to write your GSPRs to Annex I
  10. What you need to do as a Class I, IIa, IIb and Class III Medical Device.
  11. Submitting a Technical File to a Notified Body
  12. What to expect from your audit
  13. EUDAMED and Authorised Representative
  14. Post Market Surveillance, and Periodic Safety Update Report.

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FAQs

EU MDR 2017/745 is the regulation that governs the production, distribution, and use of medical devices within the European Union. It replaces the Medical Device Directive (93/42/EEC) and the Active Implantable Medical Devices Directive (90/385/EEC). The regulation aims to improve patient safety by ensuring high standards of quality and safety for medical devices.

The regulation applies to a wide range of medical devices, including:

  • Active implantable medical devices (e.g., pacemakers)
  • Non-implantable devices (e.g., surgical instruments, diagnostic devices)
  • In vitro diagnostic devices (IVDs)
  • Custom-made devices
  • Devices for aesthetic or cosmetic purposes (if they are intended to be used for medical purposes)

The regulation entered into force on May 26, 2021, and all manufacturers, importers, and distributors were required to be fully compliant with the new rules by that date. However, devices that were certified under the previous directive (MDD) could continue to be sold until May 2024, provided that they still meet the necessary safety standards. See EU commission website for up to date timelines.

  • Stricter safety requirements: New rules for clinical evaluations, post-market surveillance, and vigilance.
  • Expanded scope: The definition of medical devices has broadened, including devices that were previously outside the scope.
  • Increased role of notified bodies: Notified bodies now have more responsibilities and stricter criteria for certification.
  • Unique Device Identification (UDI): The requirement for a UDI system to improve traceability.
  • More emphasis on post-market monitoring: More detailed requirements for post-market surveillance and reporting.

A Notified Body is an organization designated by an EU member state to assess the conformity of medical devices before they are placed on the market. The Notified Body carries out the necessary checks and certifications to ensure that a medical device complies with the requirements of EU MDR 2017/745.

EU MDR places significant emphasis on the clinical evaluation process,
requiring:

  • Clinical data to support the safety and performance of the device.
  • A clinical evaluation plan outlining how data will be collected and analyzed
  • Post-market clinical follow-up (PMCF) to ensure continuous monitoring after the device is placed on the market.

The UDI is a unique code assigned to each device. It is designed to enhance the traceability of devices across the entire supply chain and improve patient safety. It helps identify devices in case of recalls, adverse events, or safety alerts. The UDI system is mandatory for most medical devices under EU MDR.

Manufacturers must implement a robust Post-Market Surveillance system to continuously monitor the safety and performance of devices after they have been placed on the market. This includes:

  • Periodic safety update reports (PSURs)
  • Collection and analysis of data from the market
  • Reporting adverse events to competent authorities

Clinical investigations are subject to stricter requirements under the EU MDR. Manufacturers must submit an application to the relevant authorities for approval, provide detailed protocols, and ensure informed consent is obtained from participants. Clinical investigations must also adhere to Good Clinical Practice (GCP) standards.

The regulation outlines the responsibilities of various economic operators,
such as:

  • Manufacturers: Responsible for ensuring the device meets all requirements.
  • Authorized Representatives: Entities in the EU representing non-EU manufacturers.
  • Importers and Distributors: Ensure that devices are compliant before being placed on the market.
  • Regulatory Affairs Professionals: Ensure ongoing compliance with the
    regulation.

The EMA is not directly responsible for medical devices under EU MDR, but it plays a role in managing certain high-risk devices (e.g., those incorporating medicinal substances). It provides scientific advice and collaborates with the European Commission and member states on policy and regulation related to medical devices.

If a device does not meet the requirements of the regulation, it cannot be placed on the market or sold within the EU. The manufacturer may face fines, withdrawal of the device from the market, or other sanctions.

Devices must have clear and accurate labeling, including:

  • UDI for traceability
  • Manufacturer details
  • Intended use
  • Safety warnings
  • Relevant standards and certifications
  • Information regarding the device’s clinical performance and risk

Yes, EU MDR 2017/745 applies to medical devices, while In Vitro Diagnostic Devices (IVDs) are covered under a separate regulation (EU IVDR 2017/746). However, both regulations share similar principles, such as ensuring safety, effectiveness, and transparency.

This list covers some of the most frequently asked questions about the EU MDR 2017/745, but the regulation is comprehensive, and specific scenarios may require more detailed answers or expert legal and regulatory advice.