EU Medical Device Regulation 2017/745 (EU MDR)

General Background

Technological innovations in the past decade have dramatically increased the number and invasiveness of medical devices. There are currently more than 500,000 medical technologies available in EU hospitals, community care settings and homes. In due course, regulators set out to increase the standards for quality, safety, and reliability of medical devices on the European market publishing two new regulations on May 25^th, 2017:

The Regulation (EU) 2017/745 on Medical Devices.
The Regulation (EU) 2017/746 on In-Vitro Diagnostic Devices.

The Medical Devices Regulation (EU) 2017/745 (MDR) replaces the Medical Devices Directive (93/42/EEC) (MDD) and the Active Implantable Devices Directive (90/385/EEC) (AIMDD) in regulating the manufacture, distribution, and handling of medical devices on the EU market. Since May 26^th, 2021, it is mandatory for all medical device manufacturers that want to place or continue to place their device/s on the European market to fully comply with the EU MDR. Transition arrangements may apply to certain manufacturers (Article 120 of the EU MDR) until the 26^th of May 2027 and 2028*.

The EU MDR is longer than the MDD and AIMDD with 100 more articles and 5 more Annexes aimed at achieving the above-mentioned improvement of quality and safety standards. Between requirements, which are completely new and other regulations, which are extended to tighten the gaps and reduce gray areas, manufacturers must plan sufficient resources to:

navigate and understand the MDR,
to identify the organizational, QMS and device related gaps,
and to implement the necessary changes

All medical device manufacturers (Class I – III), and some manufacturers of devices without an intended medical purpose (Annex XVI to Regulation (EU) 2017/745), are affected by the new regulation, and therefore obliged to make changes to their QMS and technical documentation. The extent to which the EU MDR effects the manufacturer depends on the type of device and any further actor roles the manufacturer may have. Maintenance of the CE certification issued in accordance with the EU MDR will also demand continuous and stringent monitoring of the safety and performance of the device/s on the market.

*In March 2023, the regulation EU MDR was amended to include updated transitional period in Article 120(3) with staggered deadlines depending on the risk class of the device have been entered and may apply with extensions up to 2028.

Support & Training

Contact AKRA TEAM for support, hands on implementation services and personalized training by experts with key competencies in the areas listed below, and which are relevant to the major changes introduced by the EU MDR.

Key points

Key changes that require the manufacturer´s immediate attention:

Changes to the safety and performance requirements
These are part of the 23 EU MDR 2017/745 General Safety and Performance Requirements (Annex I to Regulation (EU) 2017/745). These requirements are more defined than the 13 Essential Requirements of the former MDD 93/42/EEC and include additional requirements such as, but not limited to: increased risk management obligations, cybersecurity requirements, higher material selection requirements and requirements for devices to be used by people who are not medical professionals and disposal requirements.
Changes in device classification rules
Classification rules (Annex VIII to Regulation (EU) 2017/745) have tightened significantly resulting in a re-classification of some devices into a higher class and an introduction of a new classification. For example: spinal disk replacement devices are up-classified from Class IIb into Class III, some software devices may also fall into a higher class and reusable invasive surgical instruments have a new classification category: Class Ir.
Changes in labeling and UDI requirements
The EU MDR obliges manufacturers to ensure that the device is accompanied by information set out in Section 23 of Annex I to Regulation (EU) 2017/745 in the official Union language(s) determined by the Member State(s) in which the device is made available to the user or patient. This information includes, for example, the obligation to provide details of the EU Authorized Representative, information on the label that the device is a “Medical Device”, information of residual risk and a summary of safety and clinical performance (SSCP) for implantable devices and for class III (other than custom-made or investigational) devices. Further obligations include keeping all marketing information up to date with the instructions for use (IFU) and the addition of an implant card for implantable devices.
To increase traceability, the UDI system aims to ease reporting and identification of counterfeit medical devices. The UDI is a series of numeric or alphanumeric characters, whereby the manufacturer is responsible for complying with all UDI related requirements. This includes the assignment of the UDI (and Basic UDI-DI), the UDI (and Basic UDI-DI) registration in the EUDAMED database and the placement of the UDI carrier on the label of the device or on its packaging or, in case of reusable devices, on the device itself (direct marking). The details of this new system are communicated in the Articles 18, 19, 27, and 87 of the Regulation (EU) 2017/745.
Changes to traceability and reporting – EUDAMED
The European Databank on Medical Devices (EUDAMED) is a secured IT system and web-based portal, which shall store and provide information on devices, their manufacturers and other actors, declarations of conformity and safety data such as incidents or near incidents as well as post market surveillance activities, safety and clinical performance studies, and periodic safety update reports. Manufacturers have a series of actions to complete ensuring continuous compliance to EUDAMED obligations (Article 33 of the EU MDR).
Changes to the PMS system and vigilance requirements
Section III of the EU MDR details the requirements for manufacturers to establish and maintain a post-market surveillance process. This is applicable to all device classes, yet the details of the requirements differ as they must be proportionate to the risk class and the type of the device. The EU MDR introduces the post-market surveillance plan (Article 84), which is part of the technical documentation and the periodic safety update report (‘PSUR’) (Article 86) for class IIa, class IIb and class III devices throughout the lifetime of the device. Manufacturers of class I devices shall prepare a post-market surveillance report.
Vigilance requirements are better distinguished and bring the Legislation up to date under the EU MDR (Chapter VII Section 2 (Articles 87 to 92). The reporting deadline for “other serious incidents” is shortened to 15 days and a reporting requirement in the case of a significant increase in the frequency or severity of other incidents (Article 88), which were already required by MEDDEV 2.12/1. Manufacturers are required to submit vigilance reports to the EUDAMED database (Article 92) once the vigilance module is available.
Changes to the Clinical Evaluation
The EU MDR has more stringent requirements for Clinical Evaluation, whereby most requirements such as the Clinical Evaluation Plan were already a part of the guidance document MEDDEV 2.7/1 Rev. 4, are now explicitly listed in the Regulation 2017/745 as an obligatory process for clinical evaluation. Furthermore, the EU MDR sets clear expectations for the Clinical Evaluation Report such as the establishment of equivalence and sufficient clinical evidence. The EU MDR also introduces specific additional procedures (Annex IX section 5) for class III implantable devices, and for class IIb active devices intended to administer and/or remove a medicinal product, where the manufacturer´s notified body must provide the commission with the manufacturers clinical documentation and his clinical evaluation assessment report for a selected expert panel for transparent consultation.
Changes to obligatory roles and responsibilities within the Organization
Article 15(c) of the European MDR (2017/745), requires that manufacturers appoint at least one responsible person for regulatory compliance: PRRC (person responsible for regulatory compliance). Key compliance activities such as technical documentation, EU declaration of conformity and post-market surveillance activities are part of the PRRC´s responsibilities and the PRRC is required to have a defined level of experience and knowledge in the Medical Device Industry.
Extension of the scope of products
Products previously not categorized as “medical devices” are now governed by the EU MDR as devices without an intended medical purpose, e.g.: colored contact lenses, aesthetic dermal fillers, liposuction or lipolysis equipment and high intensity radiation equipment. The details and requirements are addressed in a separate EU MDR document: The European Commission’s common specifications for products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745, published in the Official Journal of the European Union (OJEU) L 311, 02.12.2022.
Common specifications
Article 2 (71) of the EU MDR defines ‘common specifications’ (CS) as a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process, or system. This concept is further explained in the Article IX of EU MDR, where the MDR directs the manufacturers to follow the published CS where no other harmonized standards exist or where relevant harmonized standards are not sufficient, or where there is a need to address public health concerns. The CS known thus far address different topics linked to the EU MDR, such as but not limited to the general safety and performance requirements (set out in Annex I), technical documentation (set out in Annexes II and III) and requirements for products without an intended medical purpose (listed in Annex XVI).
Specification of the role of economic operators
New regulations within economic operators provide guidelines for all stakeholders on how to execute assigned duties and help organize economic operators involved in the manufacture, import, distribution and sale of medical devices in the European Union. The economic operators include manufacturers, authorized representatives, importers and distributors. As economic operators have a critical role in ensuring safety and performance of the medical devices in the EU market, changes introduced increase traceability and accountability. The requirements for economic operators are detailed in EU MDR Article: 10, 11, 13, 14, and 30.

Our Services

Training

Akra Team can provide manufacturers with the necessary training package for the organization´s specific EU MDR competency needs. Manufacturers can request trainings and workshops in selected topics and/or general EU MDR training.

Process and Templates Development

Contact Akra Team to provide the necessary EU MDR compliant templates and/ or finalized documentation. Akra Team provides the right experts to create and maintain parts of your technical documentation such as the CERs and SSCPs, as well as QMS documentation such as SOPs for Post Market Surveillance, Vigilance and Reporting, Complaint Handling, Risk Management and more, which are necessary for an EU MDR compliant QMS.

Gap Assessment

Whether the manufacturer has begun implementing changes to their QMS and technical documentation to achieve EU MDR compliance or not, Akra Team can conduct a gap assessment. This will allow the manufacturer to develop a precise and target oriented plan in completing full EU MDR implementation in a timely manner.

Implementation

Akra Team provides hands on implementation support. The Team´s consultation and guidance ranges from providing strategic regulatory guidance and explanation of pathways their consequences to onsite and/or virtual intensive and daily collaboration with the manufacturer´s relevant employees to achieve preset goals.

Continuous update of documentation

Once EU MDR compliant documentation has been implemented and submitted to the Notified Body, it may require continuous update due to requirements such as for PMS or due to any other changes triggered by the regulators, the market, the data on the device or by the manufacturer itself. Akra team will ensure follow-up and can accompany manufacturers to maintain compliance.

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EU Medical Device Regulation 2017/745 (EU MDR)

General Background

Support & Training

Key points

Changes to the safety and performance requirements

Changes in device classification rules

Changes in labeling and UDI requirements

Changes to traceability and reporting – EUDAMED

Changes to the PMS system and vigilance requirements

Changes to the Clinical Evaluation

Changes to obligatory roles and responsibilities within the Organization

Extension of the scope of products

Common specifications

Specification of the role of economic operators