Medical Device Regulation (MDR)

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.

Download the MDR Service Description (NB 0123)

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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 Bodiesy and related Certification Bodies, while our testing services are conducted through TÜV SÜD Testing Labs.

Timelines for MDR technical documentation

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.

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.

What our MDR service include

Here are the three stages of pre-application, application and assessment you will go through to demonstrate MDR compliance.

The MDR auditing process

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.

MDR technical documentation assessment procedure overview

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.

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.

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, 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.