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What is medical device regulation (MDR)
The European Union (EU) published the Medical Device Regulation (MDR) in April 2017 to harmonise the regulatory review and approval process of medical devices across all EU Member States. The requirements of the MDR became applicable to all medical devices sold in the EU in May 2021.
This is a mandatory requirement for businesses that wish to sell their medical devices in the EU which is one of the world’s largest medical device markets. The market is worth approximately €150 billion in 2022 and expected to reach €170 billion by 2027.
The complexity in developing new and advanced medical devices makes the regulatory approval process challenging for many device manufacturers. The rigorous requirements embodied in the MDR add to the complexity. Even manufacturers of medical devices previously approved under the MDD or AIMDD are not exempt from the MDR’s requirements. Legacy devices still being sold on the market must be recertified in accordance with the MDR’s provisions.
Further, except for Class I devices, manufacturers must involve an EU Notified Body such as TÜV SÜD to approve and certify all medical devices that fall within the scope of the MDR. Manufacturers should consult with a Notified Body such as TÜV SÜD early in product development to plan the steps necessary for timely and efficient MDR review and certification. Advanced preparation and early action are key.
How TÜV SÜD can help you with MDR
TÜV SÜD with its Notified Bodies (0123 and 2443) covers the full scope of the MDR and supports companies of all sizes from SMEs to larger-scale organizations. Both Notified Bodies are managed within the MDR portfolio of TÜV SÜD AG and are thus part of the globally operating Medical & Health Services (MHS) business unit and has specialised expertise in innovative cardiological, neurological and orthopaedic medical devices, as well as software innovations.
TÜV SÜD supports medical device and IVD manufacturers by providing testing, inspection, and certification services, thereby ensuring the safety, security, and market access of medical devices and IVD medical devices.
TÜV SÜD Product Service GmbH was among the world's first Notified Bodies to receive designation as a Notified Body for the MDR by the Central Authority of the countries for Health Protection with regard to Medicinal Products and Medical Devices (ZLG).
On 6 April 2024 TÜV SÜD Danmark ApS received its designation as Notified Body 2443 under Medical Device Regulation 2017/745 by the Danish Medicines Agency (DKMA).
With this additional Notified Body under MDR 2017/745, TÜV SÜD is extending its capabilities and knowledge with a team of experts located across the globe.
With more than 750 medical device professionals in more than 30 locations worldwide, we are one of the largest EU Notified Bodies globally authorised to provide certification services under the MDR.
We have steadily built up our MDR certification capacities and are in close contact with manufacturers to explain them on the complex and time-consuming processes.
TÜV SÜD's certification and testing services are independent of each other and do not impact one another. Our certification services are delivered by TÜV SÜD's recognised Notified Bodies and related Certification Bodies, while our testing services are conducted through TÜV SÜD Testing Labs.
Updated timeline of EU MDR transition
On 15 March 2023, the Regulation (EU) 2023/607 was published, which provides medical device manufacturers more time to certify medical devices under MDR to mitigate the risk of shortages. The amended regulation introduces a longer transition period to adapt to new rules under the MDR for products already on the market under the MDD/AIMDD.
It’s important to note that the extension of the transition period to the new rules is subject to certain conditions. More time will only be granted for products that are safe and for which manufacturers have already taken steps regarding the transition to MDR.
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 built up capacities and is in constant close exchange with manufacturers on the changeover. However, manufacturers must also become active and work at full speed on the planning, to avoid any delays at the end of the transition timelines.
It’s important to note that the extension of the transition period to the new rules is subject to certain conditions. More time will only be granted for products that are safe and for which manufacturers have already taken steps regarding the transition to MDR.
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 built up capacities and is in constant close exchange with manufacturers on the changeover. However, manufacturers must also become active and work at full speed on the planning, to avoid any delays at the end of the transition timelines.
Timelines for MDR technical documentation
We can serve our customers according to their individual readiness. We can expedite parts of the technical documentation, processing them with the highest priority.
The diagram below shows a comparison of our basic and expedited service models for MDR certification. Please note that these are target timelines. Individual timelines for each of our customers may differ. Fast track available in selected regions.
The diagram below shows a comparison of our basic and expedited service models for MDR certification. Please note that these are target timelines. Individual timelines for each of our customers may differ. Fast track available in selected regions.
The MDR Auditing process
For products that are classified as Class Is/Im/Ir/II/III medical devices, the Medical Device Regulation (MDR) requires an assessment of the technical documentation within the scope of the MDR conformity assessment procedure to place devices on the EU market.
To bring medical devices into the EU market, depending on the classification and chosen MDR conformity assessment procedure the legal manufacturer may need an additional EU technical documentation assessment certificate besides his EU quality management or quality assurance system certificate.
In the case of initial product certification, the process starts with a combined pre-application and application phase to ascertain that a product can be certified from a regulatory point of view.
In the case of modification of a certified product the process starts directly with the change related application phase.
Pre-Application Phase – for a new medical device(initial certification) | Application Phase – for changes on a certified medical device(change notification) |
|---|---|
In the MDR conformity assessment (pre-)application phase for EU MDR certification, an application for certification is sent to TÜV SÜD and processed between the Notified Body (TÜV SÜD) and the manufacturer. Submission of the data triggers the quotation process and initiates the application phase, including the application review to ensure regulatory compliance and the feasibility of certification. | In the case of modification of a MDR certified product, the process starts with the change related to MDR certificate. |
Download documentation checklists for structured data assessment. | Download documentation checklists for structured data assessment. |
The next step in both processes is the assessment of the MDR technical documentation. A positive result of the review and the independent certification decision enables the issuance of the related certificate.
Technical Documentation (TD) Assessment
The MDR Conformity Assessment and the needed resources are planned in accordance with your service's chosen timeline. To ensure adherence to the scheduled timelines for the first and second rounds of assessment, resources are planned in consultation with the Technical Documentation assessment experts.
MDR pre-application and auditing process
Once you have registered on our website, and resources are available, you will receive our MDR Conformity Assessment pre-application forms. We use the data collected in these pre-application forms to draw up your quotation. Acceptance of our quotation represents the start of the MDR Conformity Assessment application phase, which includes a more in-depth check of your MDR Conformity Assessment application documents.
MDR auditing process stage 1(initial audit) | MDR auditing process stage 2 |
|---|---|
The stage 1 audit forms part of the initial audit for all first-time applicants for MDR conformity assessment. The stage 1 audit can be conducted on- or off-site depending on the circumstances. In the stage 1 audit, the auditors check whether your company’s QMS is ready to be for Stage 2 audit. | Once the client response to all the areas of concerns from the stage 1 audit are accepted, a stage 2 audit can be conducted. The stage 2 audit covers all sites of relevance for the products you want to place on the market, including manufacturing and design and development sites. The duration of the stage 2 audits depends on various factors including company size and the number of sites to be covered. After the audit, the client shall respond to all findings and this must be accepted by our auditors. |
Possible topics for structured dialogue:
Application & Onboarding
- Onboarding process
- Application forms & review process
- Sites, suppliers & devices
- Device classification & code assignment
Topics of manufacturer
- TÜV SÜD Testing & Certification Regulations
- MDR/IVDR Framework Agreement
- Handling of device and other changes
- Transfer to TÜV SÜD Notified Body
Conformity Assessment Procedure
- Project planning, time limits special procedures (e.g. consultation)
- Submission requirements
- Costs, fees & other financial aspects
- CS, guidance documents & harmonized standards
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 with TÜV SÜD Notified Body:
- If you wish to engage TÜV SÜD as a Notified Body and kickstart the Structured Dialogue process, please request a reachout.
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 with TÜV SÜD Notified Body: If you wish to engage TÜV SÜD as a Notified Body and kickstart the Structured Dialogue process, please request a reachout.
Key requirements of the EU MDR
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 not have 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 now 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. This results 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 now required to conduct clinical investigations to support claims of both safety and performance in a medical device in cases where sufficient clinical evidence is not available. Manufacturers are also required to collect and retain post-market clinical data as part of the ongoing assessment of potential safety risks.
Systematic clinical evaluation of Class IIa and Class IIb medical devices
Manufacturers should carefully consider the MDR’s strict requirements on the use of evidence of equivalence to determine 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 such as TÜV SÜD now need to be involved in the conformity assessment of class I reusable surgical instruments relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance and functional testing and the related instructions for use or 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 reduce risks from unsafe devices. Annual safety and performance reporting by device manufacturers is also required in many cases.
FAQ
What is the Medical Device Regulation (MDR)?
The Medical Device Regulation (MDR) replaced the EU’s original Medical Device Directive (93/42/EEC MDD) and the EU’s Directive on active implantable medical devices (90/385/EEC AIMDD).
When was the MDR implemented?
The MDR came into force on 25 May 2017 and became applicable on 26 May 2021.
When did the MDR take effect?
The EU’s MDR requirements were originally scheduled to take full effect in May 2020, providing manufacturers with a three-year transition period to bring existing medical devices into compliance with the MDR’s requirements. The MDR was amended in April 2020 to extend the Date of Application to 26 May 2021. As of that date, new medical devices placed in the European market must meet the requirements of the MDR.
However, the implementation of certain MDR provisions will be postponed until December 2028 for medical devices previously approved under the Medical Devices Directive 93/42/EEC (MDD) and Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) or covered by Declaration of Conformity (DoC) issued before 26 May 2021. The extended transition periods are:
26 May 2026 – for class III custom-made implantable devices
31 December 2027 – for higher-risk products (class III devices and class IIb implantable devices, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors)
31 December 2028 – for medium and lower risk products (other class IIb devices, class IIa devices, and class ls, lm, lr)
However, the implementation of certain MDR provisions will be postponed until December 2028 for medical devices previously approved under the Medical Devices Directive 93/42/EEC (MDD) and Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) or covered by Declaration of Conformity (DoC) issued before 26 May 2021. The extended transition periods are:
26 May 2026 – for class III custom-made implantable devices
31 December 2027 – for higher-risk products (class III devices and class IIb implantable devices, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors)
31 December 2028 – for medium and lower risk products (other class IIb devices, class IIa devices, and class ls, lm, lr)
How do the requirements in the MDR differ from those in the MDD/AIMDD?
Product scope expansion – Devices not previously covered under the MDD and AIMDD are now covered.
Reclassification of devices – Annex VIII of the MDR details the requirements.
More rigorous clinical evidence for class III and implantable medical devices – Manufacturers need to conduct clinical investigations to support claims of both safety and performance in a medical device in cases if sufficient clinical evidence is not available.
Systematic clinical evaluation of Class IIa and Class IIb medical devices – The MDR has strict requirements on the use of evidence of equivalence.
More stringent documentation – Annexes II and III of the MDR detail the applicable requirements.
Identification of “person responsible for regulatory compliance” – Manufacturers should identify at least one person within their organisation who is responsible for compliance.
Implementation of unique device identification for better traceability and recall – The MDR mandates the use of unique device identification (UDI) mechanisms.
More rigorous surveillance by Notified Bodies to reduce risks from unsafe devices.
Reclassification of devices – Annex VIII of the MDR details the requirements.
More rigorous clinical evidence for class III and implantable medical devices – Manufacturers need to conduct clinical investigations to support claims of both safety and performance in a medical device in cases if sufficient clinical evidence is not available.
Systematic clinical evaluation of Class IIa and Class IIb medical devices – The MDR has strict requirements on the use of evidence of equivalence.
More stringent documentation – Annexes II and III of the MDR detail the applicable requirements.
Identification of “person responsible for regulatory compliance” – Manufacturers should identify at least one person within their organisation who is responsible for compliance.
Implementation of unique device identification for better traceability and recall – The MDR mandates the use of unique device identification (UDI) mechanisms.
More rigorous surveillance by Notified Bodies to reduce risks from unsafe devices.
What are the implications of the MDR for medical device manufacturers?
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 were previously approved under the MDD or the AIMDD are not exempt from the MDRs requirements, and legacy devices still being sold on the market must be recertified in accordance with the MDR’s provisions.
Further, except for Class I devices, an EU Notified Body must be involved in the approval and certification of all medical devices that fall within the scope of the MDR. Given the expanded scope of medical 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.
Further, except for Class I devices, an EU Notified Body must be involved in the approval and certification of all medical devices that fall within the scope of the MDR. Given the expanded scope of medical 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.
What constitutes a significant change under MDR transitional provisions, article 120?
The Medical Device Coordination Group (MDCG) has published MDCG 2020-3, “Guidance on significant changes regarding the transitional provision under Article 120 of the MDR” In its review of medical devices, TÜV SÜD will apply those criteria signifying “significant change in design or a significant change in the intended purpose” as detailed in the MDCG guidance.
By what date must the number of the notified body appear on class I reusable devices?
Devices categorised under the MDD as a Class I reusable surgical instrument did not require the involvement of a Notified Body. With the MDR an involvement is necessary for those devices (Class Ir). Further these are subject to the provisions of the amendment REGULATION (EU) 2023/607 and may continue to be placed on the market until 31 December 2028. Afterwards, the device needs a certification by a MDR Notified Body, and the respective labelling with the number of the NB.
The amendment REGULATION (EU) 2023/607 applies also to devices that fall under Class I sterile (Is) and Class I with a measuring function (Im). The new timelines do not apply to Class I devices that do not have a current MDD certificate and do not require a MDR certificate.
However, extension of transition period to the new rules is subject to certain conditions. More time will only be granted for products that are safe and for which manufacturers have already taken steps regarding the transition to MDR:
This means that the application must be submitted latest by 26 May 2024 and the contractual agreement with TÜV SÜD must be concluded latest by 26 September 2024.
The amendment REGULATION (EU) 2023/607 applies also to devices that fall under Class I sterile (Is) and Class I with a measuring function (Im). The new timelines do not apply to Class I devices that do not have a current MDD certificate and do not require a MDR certificate.
However, extension of transition period to the new rules is subject to certain conditions. More time will only be granted for products that are safe and for which manufacturers have already taken steps regarding the transition to MDR:
This means that the application must be submitted latest by 26 May 2024 and the contractual agreement with TÜV SÜD must be concluded latest by 26 September 2024.
Do I need to recall class I reusable devices to re-label them?
No, there is no requirement to recall Class I reusable devices which are placed on the market under the MDD before the Date of Application of the MDR. In general, devices that have been lawfully placed on the market under the MDD or the AIMDD before the MDR Date of Application can be made available and put into service until 31 December 2028, subjected to certain conditions mentioned in section 7.
Where can I get more information about MDR?
Our guide on the expected changes of the MDR is available under the knowledge highlights section. You can also follow the TÜV SÜD LinkedIn showcase page for Healthcare & Medical Devices for the latest information.
How do I prepare for the MDR?
It is highly advisable to stay informed about the requirements and deadlines of the MDR. Our guide on the key changes of the MDR is available under the knowledge highlights section. Also, it is important to assess how your current product portfolio may be impacted by the regulations.
What is the MDR impact on certification cost?
The MDR application and the auditing and designation processes require extensive effort from Notified Bodies, creating various unexpected costs reflected in the pricing for relevant services. Moreover, Notified Bodies have been required to restructure their organisations and increase resources to provide relevant services, thus increasing overall costs. Finally, the MDR requires increased regulatory oversight which involves additional and regular assessment, resulting in higher total certification costs over a 5-year period.
Our MDR Conformity Assessment Procedure TÜV SÜD PS GmbH for the latest MDR certification cost is available under the knowledge highlights section.
Our MDR Conformity Assessment Procedure TÜV SÜD PS GmbH for the latest MDR certification cost is available under the knowledge highlights section.
How to request TÜV SÜD MDR services?
Since receiving designation and notification as a MDR Notified Body, TÜV SÜD has received many requests for MDR certification. We take our responsibility as a designated Notified Body seriously and make every possible effort to support a smooth implementation of the regulation and avoid any negative impact on the European healthcare system. It is critical that a continued supply of safe and effective medical devices is available for patients.
Please contact us using our online portal at www.tuvsud.com/mdrenquiry.
Please contact us using our online portal at www.tuvsud.com/mdrenquiry.
Start your MDR journey with us.
