EU MDR (2017/745) covers medical device regulation in the EU. Regulation EU 2023/607 extends the transition period for products certified under MDD/AIMDD to adapt remain on the market under certain conditions.
EU MDR (2017/745) covers medical device regulation in the EU. Regulation EU 2023/607 extends the transition period for products certified under MDD/AIMDD to adapt remain on the market under certain conditions.
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.
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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 Bodiesy and related Certification Bodies, while our testing services are conducted through TÜV SÜD Testing Labs.
TÜV SÜD with its Notified Bodies (0123 and 2443) can serve our customers according to their individual readiness. We can expedite parts of the technical documentation, processing them with the highest priority.
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.
Here are the three stages of pre-application, application and assessment you will go through to demonstrate MDR compliance.
The most common conformity assessment procedure for medical devices higher than class I is the procedure following Annex IX of the MDR. This annex requires assessment of the quality management system and – depending on the classification of the medical devices concerned – assessment of the technical documentation.
At TÜV SÜD, an initial conformity assessment procedure in accordance with Annex IX starts with the (pre-) application phase. Once this phase is completed, the assessment of technical documentation starts followed by an initial audit. This initial audit comprises two stages, a “stage 1 audit” and a “stage 2 audit”. The certification phase commences when all technical documentations have been assessed with a positive result and when the client has responded to all the non-conformities. In the certification phase the certification body performs an independent assessment of activities conducted by the Technical Documentation assessment experts and auditors. As soon as any questions and concerns have been closed certification can be granted.
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.
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Pre-Application Phase – for a new medical device |
Application Phase – for changes on a certified medical device |
| 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. A quotation for the review process is prepared based on and tailored to the contents of the application to be assessed. After an independent review of the application with a positive result, the assessment of the change can be started. A positive result of the review and the independent certification decision enables the issuance of a revision of the related certificate. |
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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.
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.
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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. Once the response is accepted and all technical documentation finalised with a positive result, the certification phase starts. |
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, forms and submission documents.
These structured dialogues are limited to meetings with clients before the application for a conformity assessment and are independent of the assessment. We also have the utmost intention of being independent, impartial and objective. Therefore, 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.
Application & Onboarding
Topics of manufacturer
Conformity Assessment Procedure
Existing clients with TÜV SÜD Notified Body
Potential clients with TÜV SÜD Notified Body:
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).
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.
The EU is one of the largest markets for medical devices in the world. With 747.64 million citizens in EU as of 2020, double the population of United States at 333 million, total medical device sales in the EU are expected to exceed €170 billion by 2027, driven in part by technological advancements such as artificial intelligence (AI) and remote monitoring capabilities. This makes the EU an important market for all medical device manufacturers, from major corporations to innovative start-up entities.
The most significant requirements in the MDR include:
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.
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.
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.
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.
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.
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.
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.
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.
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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