MDR Medical Devices Regulation (EU 2017/745)

What is the MDR?

As from 26 May 2021, it is mandatory to apply the new EU Medical Devices Regulation (MDR; EU 2017/745), which replaces the existing Medical Device Directive (MDD; 93/42/EEC). The MDR governs the approval of medical devices such as blood pressure monitors and clinical thermometers, and aligns EU legislation with technical advances and changes in medical science. This has resulted in expanded rules and obligations for everyone in the supply chain, which must be considered and implemented independently by the parties concerned.

Beurer ensures that its medical devices are switched over from the MDD to the MDR in good time, allowing customers to continue ordering devices without hesitation. Transitional provisions are in place to avoid market disruption and allow a smooth transition.

Deadlines for implementing the MDR

The MDR implementation involves several key dates:

• 25/05/2017: MDR enters into force.
• Transition period of 4 years following entry into force.
• 26/05/2021: Date of application of MDR.
• 25/05/2024: Final date for placing devices on the market according to the MDD, provided they have a valid MDD certificate from the manufacturer.
• 27/05/2025: Devices approved according to the MDD are no longer permitted to be sold or offered to consumers.

Note: 26 May 2025 is the final cut-off date for selling devices already placed on the market (e.g., in distributors' stock). Blood glucose monitors, test strips, and control solutions fall under Annex II List B (IVDD) / Annex VIII Class B (IVDR). The IVDR entered into force on 25 May 2017 and applies from 26 May 2022.

* Postponement to the start of validity by one year, as decided by European Parliament on 17.04.2020, due to the Covid-19 pandemic.

Who is who?

The MDR establishes standardised regulations across all EU countries concerning the safety, traceability, and transparency of medical devices.

As a Beurer customer, you typically act as a "distributor". This section outlines additional tasks and obligations under the MDR.

If a distributor sells a device to a reseller, the distributor must provide the CE declaration. The reseller is part of the supply chain and subject to the same obligations as a distributor.

Roles and Responsibilities:

Overview of Obligations for Distributors

Distributors must ensure, through representative sampling, that distributed medical devices comply with the obligations described in Art. 14 of the Medical Devices Regulation.

Inspection of Device and Documentation (MDR Art. 14 (2))

• The device must be CE marked.
• The EU Declaration of Conformity must be available. If missing, it can be downloaded from the Beurer website.
• Labels and instructions for use must be provided in the official languages of the Member States where the device is made available (or accepted languages).
• The manufacturer's name must be indicated on the device or documentation.
• NEW: Where applicable, the device must have a UDI (Unique Device Identifier). During transition periods, devices may not have a UDI but are still classed as medical devices.

Distributors must also:

• Inform authorities and other economic operators if they suspect a device is falsified or poses a serious health risk.
• NEW: Maintain a register of complaints, non-conforming devices, recalls, and withdrawals.
• Cooperate with authorities and provide all requested information, documentation, and device samples.
• Immediately report any complaints or suspected incidents related to a device to the manufacturer.

The current reporting addresses for Beurer and Sanitas devices are available on page 11.

Assurance of Storage and Transport Conditions (MDR Art. 14 (3))

Storage and transport conditions recommended by the manufacturer must be complied with, as stated on the decorative box and in the instructions for use.

Reporting Procedure & Documentation (MDR Art. 14 (2) - (6))

• If a device is non-compliant, it is prohibited to sell it.
• If there's a reason to suspect a device deviates from the Regulation, the distributor must inform the manufacturer immediately.

Documentation of the Supply Chain

For a minimum of 10 years, economic operators must document how their devices were distributed: from whom they were purchased and to whom they were handed. This obligation ends when the device is handed over to a patient or private consumer. Details of end customers do not need to be recorded, even if sold via a pharmacy. This documentation requirement also applies when handing over devices to health institutions, though specifics are still being clarified.

Unique Device Identifier (UDI)

UDI stands for UNIQUE DEVICE IDENTIFIER. The MDR mandates that all medical devices feature this code in the future. The UDI system aims to improve the identification and traceability of medical devices. Information is provided in plain text and machine-readable format (barcode or matrix code).

Deadlines for applying UDI:

• Class III: by 26 May 2021
• Class IIa and IIb: by 26 May 2023
• Class I: by 26 May 2025
• Reusable medical devices (UDI carrier applied directly): 2 years later than the above dates (2023, 2025, or 2027).

The purpose of the UDI is to enable individual device recalls, which is relevant for distributors in the event of a recall.

Example UDI structure (Fig. FT 90):

The image shows a sample label with:

• UDI code as a matrix code and plain text: (01)00842768025587
• Serial number: (21)123FOBA, SN 124365645

*The image shown is for illustrative purposes only; the actual depiction may vary.

How Can I Identify a Medical Device?

1.0 List of Medical Devices

Check if the device is included in the list of Beurer medical devices (see page 9).

2.0 Type Plate

A device is identifiable as a medical device if points 2.1 and 2.2 apply.

2.1 CE Marking

• Class I medical device: CE marking without a 4-digit number.
• Class IIa/IIb medical devices: CE marking with a 4-digit number (e.g., CE0483).

Example Type Plate Information:

Beurer GmbH, Söflinger Str. 216, 89077 Ulm, Germany. Type: BM 45, Item No.: 658.06. Measuring range: 40-250 mmHg. Power: 6V (4 x 1.5V AA). Mains part: 6V === 600 mA. Manufacturer of mains adapter: Shenzhen longxc power supply co., ltd, LXCP12-006060BEH (optional). LOT. CE 0483 CI. I.

Another example shows CE0483 with CI. IIa/IIb.

2.2 The "MD" Symbol

If the "MD" symbol is included on the type plate, the device is a medical device that complies with the MDR. This is a new marking for MDR-compliant medical devices.

Previous type plate for medical device (MDD): no additional marking.

3.0 Instructions for Use

If the instructions for use contain statements such as:

• "This device meets the requirements of the EU Directive 93/42/EEC concerning medical devices, as well as those of the Medizinproduktegesetz (German Medical Devices Act), and [...]"
• OR "The device complies with the Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices, as well as the respective national provisions [...]"

then the device is compliant.

In order to prevent delivery bottlenecks, it is recommended to switch over in good time. Beurer is ready and will comply with MDR deadlines.

Which devices from Beurer/Sanitas are classed as medical devices?

*dependent on the legal regulations in the specific country

Note: As at May 2020, Beurer does not offer medical devices from Class Is, Im, Ir or III.

FAQs

Which Beurer devices are affected by the MDR and what are the key deadlines?

Medical devices are categorised into four classes: I, IIa, IIb, and III, based on duration of use, invasiveness, and reusability. Classes Is, Im, Ir, IIa, IIb, and III require assessment and certification by a Notified Body. Certificates issued under the previous MDD remain valid for their specified period. Beurer renewed certificates in 2019, allowing certified devices under MDD until 26 May 2024. Class I devices, previously not requiring certification, must be MDR compliant from 26 May 2021.

Note: 26 May 2025 is the final cut-off date for selling devices already placed on the market (e.g., in stock).

As from May 2021 will I still receive all the devices that I previously purchased?

Manufacturers face significant time and expense obtaining MDR certification. This may lead to familiar devices becoming unavailable. However, Beurer will have switched over all Class I devices to MDR by May 2021. Selected higher-class devices will be switched over by 26 May 2024 at the latest. 26 May 2025 is the final cut-off for selling MDD-compliant devices already on the market.

As a distributor, what exactly do I need to document under the MDR?

For a minimum of 10 years (MDR Art. 10, Section 8), distributors must document how their devices were distributed: from whom they were purchased and to whom they were handed. This proof obligation ends when the device is handed to a patient or private consumer. Details of end customers do not need to be recorded, even if sold via a pharmacy. This documentation also applies when handing over devices to health institutions, though specifics are not yet definitively clarified.

Where can I find more information about the MDR?

More information is available on the EU website "Getting ready for the new regulations":

• https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/getting-ready-new-regulations
• For distributors and importers: https://ec.europa.eu/growth/sectors/medical-devices/getting-ready-new-regulations/authorised-representatives-importers-and_en

European database on medical devices - EUDAMED

• A central platform for information on manufacturers, devices, certifications, and clinical trials.
• Access rights are to be determined (t.b.d.).
• Available online from May 2022: https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/eudamed_en

Downloads and reporting addresses for Beurer and Sanitas

• CE Declarations of Conformity: https://www.beurer.com/mdr
• Current reporting address for Beurer devices: Available via www.beurer.com → Service → Service addresses. https://www.beurer.com/web/gb/service/international-service-adresses.php
• Current reporting address for Sanitas devices: E-mail: service@sanitas-online.de