Medical device regulation (MDR)

Meeting the Requirements of the EU’s Medical Device Regulation (MDR 2017/745)

How to Achieve EU Market Access for Medical Devices

How to Achieve EU Market Access for Medical Devices

HOW TÜV SÜD CAN HELP MANUFACTURERS ACHIEVE MDR 2017/745 COMPLIANCE

TÜV SÜD was among the world's first organisations to receive designation as a Notified Body for the European Union’s MDR (Regulation (EU) 2017/745).

With 2 EU notified bodies and more than 750 medical device professionals in more than 30 locations worldwide, we are one of the largest organisations providing certification services under the EU MDR 2017/745.

A. REQUEST FOR MDR SERVICE REGISTRATION

Request assistance with the MDR 2017/745 certification process through our form below or contact us at [email protected].

Request for a MDR service registration today

  • For language requirements of documentation submissions, please refer to the respective Conformity Assessment Procedure pages below.

B. Notified bodies conformity assessment PROCEDURE & FAQS

Manufacturers need to apply for a suitable conformity assessment procedure from a Notified Body based on their product classification. You can learn more about TÜV SÜD’s MDR services by visiting the respective TÜV SÜD Notified Bodies webpages on MDR Application Procedure.

You can also find out more information about the EU’s MDR 2017/745 by visiting our Frequently Asked Questions page.

C. STRUCTURED DIALOGUE

The purpose of a structured dialogue prior to lodging a formal MDR application with TÜV SÜD is to clarify the timing, procedural, and regulatory aspects of the application process and forms, and the submission documents.

These structured dialogues are limited to meetings with clients before the application for a conformity assessment and are independent of the assessment. Therefore, and to show the utmost intention of being independent, impartial, and objective, the structured dialogue service shall be ordered independently from the MDR framework agreement.

Expand the tabs below to find out the possible topics, process and how to apply for Structured Dialogue.

  • Possible topics for Structured Dialogue

    Pre-application and application process:

    • Pre-application form, review process outcomes, and implications
    • Application form, review process, outcomes, and implications
    • QMS, Technical documentation, and Clinical Self-assessment forms
    • Service model and options
    • Costs, fees, and other financial aspects

     

    Obligations for the manufacturer:

    • TÜV SÜD Testing and Certification Regulations 
    • Framework Agreement
    • Sites, suppliers, devices, and other aspects
    • Device classification and MDR code assignment 
    • Explanation of Device - novelty – intended purpose – benefit risk criteria, Clinical data generated
    • Vigilance reporting
    • Handling of device and other changes
    • Recertification
    • Transfer from/to another notified body

     

    Conformity Assessment Procedure

    • General information on the conformity assessment procedures
    • Submission requirements
    • Planning of the assessment
    • Sampling requirements
    • Project planning, time limits, and special procedures such as consultation with competent authorities
    • Common specifications, guidance documents, position papers, and harmonized standards
    • Regulations and standards relevant to the product, technologies, critical materials, and further relevant aspects
  • Structured Dialogue process

     

    Structured dialogue process

  • How can I apply for Structured Dialogue

    Existing clients with TÜV SÜD Notified Body

    • If you are an existing client, please get in touch with your dedicated client manager to move forward

    Potential clients:

    • If you wish to engage TÜV SÜD as a Notified Body and kickstart the Structured Dialogue process, please fill up the following request form: MDR

What is European Union (EU) Medical Device Regulation (MDR)

Published in the Official Journal of the European Union in April 2017, the European Union’s (EU) Medical Device Regulation (Regulation (EU) 2017/745) was developed to reflect the significant progress in medical device technologies that had taken place since the implementation of the EU’s initial framework in the 1990s, and to harmonize the regulatory review and approval process across all EU Member States.

The requirements of the MDR became applicable to all medical devices sold in the EU as of 26 May 2021. Currently, the implementation of certain MDR provisions will be extended until as late as 31 December 2028 for medical devices that were previously approved under the Medical Devices Directive 93/42/EEC (MDD) and Active Implantable Medical Devices Directive 90/385/EEC (AIMDD).

Updated Timeline of EU MDR Transition timeline 

On 15 March 2023, the Regulation (EU) 2023/607 was formalised, which provides medical device manufacturers more time to certify medical devices to mitigate the risk of shortages. The amended regulation introduces a longer transition period for products already on the market under the MDD/AIMDD.

Refer to the MDR FAQs for more information on the key elements of new MDR transition timelines.

TÜV SÜD continues to strongly encourage manufacturers to act now, despite the new deadlines. The procedure of the EU MDR is known to be complex and sometimes requires longer processing times. TÜV SÜD has, at an early stage and steadily, built up capacities and is in constant close exchange with manufacturers on the changeover. However, manufacturers must also become active in the already well known situation and work at full speed on the transformation, to avoid any delays at the end of the transition period.

Request for a MDR service registration today

 

KEY REQUIREMENTS OF THE EU’S MDR

The most significant requirements in the MDR include:

  • Product scope expansion

    The MDR applies to an expanded range of medical devices including products that were not previously covered by the MDD and AIMDD. Specific examples of newly covered medical devices include those that do have not a medical intended purpose, such as coloured contact lenses and cosmetic implant devices and materials. Also included in the scope of the MDR are devices designed for the purpose of “prediction and prognosis” of a disease or other health condition.

  • Identification of “person responsible for regulatory compliance”

    Device manufacturers are required to identify at least one person within their organisation who is ultimately responsible for all aspects of compliance with the requirements of the MDR. The organisation must document the specific qualifications of this individual relative to the required tasks. Special relief for some of these provisions may be applicable to small enterprises and start-up entities.

  • Reclassification of devices according to risk, contact duration and invasiveness

    Annex VIII of the MDR details the requirements governing the classification of medical devices. In several instances, the MDR classification requirements are more rigorous than those in the MDD or AIMDD, resulting in the assignment of a higher risk class for some devices and the need to meet more stringent requirements than in the past.

  • More rigorous clinical evidence for class III and implantable medical devices

    Device manufacturers are always required to provide sufficient clinical evidence to support safety, performance and – in addition as a new requirement – the benefit of a medical device – no matter which risk class the medical device is in. Clinical investigations are still mandatory, if no sufficient clinical data from other sources are available – this is also not depending on the risk class of the medical device (MDR Art 61). For all devices, the manufacturer shall have a clinical evaluation plan as described in MDR Annex XIV Part A, where the manufacturer shall provide expected outcome parameters for safety, performance, and benefit. 

    Certain devices, such as implantable devices and class III devices have their own MDR rules concerning the necessity of a clinical investigation (MDR Art 61.4). The widely used equivalence approach became more rigorous for these class III and implantable devices (MDR, Annex XIV Part A) due to a required contractual agreement between the manufacturer of the device under assessment and the manufacturer of the equivalent device to ensure access to the technical documentation (MDR, Art 61.5). For implantable devices and for class III devices the manufacturer must annually provide a publicly available document that contains detailed clinical data on safety, performance and benefit of the medical device – the so-called Summary of Safety and Clinical Performance (SSCP) - that is not only understandable for professional users of the medical device – but also understandable for the patient, if applicable. This document will be publicly available on the EUDAMED database. The SSCP is one part of the dedicated post market surveillance process that a Manufacturers must comply with (MDR Art. 32). The post market surveillance process specifically to clinical data is governed in detail in MDR Annex XIV Part B under Post Market Clinical Follow Up. 

    For implantable class III devices and class IIb devices according to Rule 12, a new consultation process has been initiated: The Clinical Evaluation Consultation Procedure (CECP). An independent Expert Committee from the EU Commission will review the clinical evaluation assessment report of the Notified Body and will provide an additional scientific opinion on the result of the clinical data assessment (MDR Art 54).

  • Systematic clinical evaluation of Class IIa and Class IIb medical devices

    Manufacturers are still required to carefully consider the MDR’s requirements on the use of evidence of equivalence in determining whether or not a clinical investigation is required.

  • Implementation of unique device identification

    The MDR mandates the use of unique device identification (UDI) mechanisms with medical devices. This requirement is intended to support the ability of manufacturers and authorities to trace specific devices through the supply chain, and to facilitate the prompt and efficient recall of medical devices that have been found to present a safety risk. In addition, the European Databank on Medical Devices (Eudamed) has been expanded to provide more efficient access to information on approved medical devices.

  • Reusable surgical instruments and NBs

    Notified Bodies now need to be involved in the conformity assessment of class I reusable surgical instruments towards the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance and functional testing and the related instructions for use or the reprocessing.

  • Rigorous post-market oversight

    The MDR mandates increased post-market surveillance (PMS) authority by the Notified Body. Unannounced audits, along with product sample checks and product testing will strengthen the EU’s enforcement regime and help to reduce risks from unsafe devices. Annual safety and performance reporting by device manufacturers is also required in many cases.

The challenges of certification and the role of notified bodies

The complexity in developing new and advanced medical devices, combined with the rigorous requirements embodied in the EU’s MDR, are likely to make the regulatory approval process challenging for many device manufacturers. Even manufacturers of medical devices that previously held certificates under the MDD or the AIMDD are not exempt from the MDR’s requirements, and legacy devices still being sold on the market must be newly certified in accordance with the MDR’s provisions. 

Further, with the exception of Class I devices [1], an EU Notified Body must be involved in the conformity assessment procedure of all devices that fall within the scope of the MDR. Given the expanded scope of devices that require Notified Body review and approval, delays in the review and approval process should be anticipated. Device manufacturers are advised to consult with a Notified Body early in the product development process to plan the steps necessary to achieve timely and efficient MDR review and certification. Advanced preparation and early action are key.

[1] class I devices placed on the market in sterile condition, have a measuring function or are reusable surgical instruments need the involvement of a notified body 

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