Information on the new EU Medical Device Regulation 2017/745 (MDR)

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What is the MDR?

The MDR (Medical Device Regulation) is the new European medical device regulation. It entered into force on May 25, 2017, and its date of application is mandatory as of May 26, 2021. The regulation forms the new EU legal framework for medical devices and replaces the previous Medical Device Directive (MDD (93/42/EEC)).

The MDR defines extended obligations for all economic operators (including manufacturers and distributors) who are part of the supply chain of a medical device. Compliance with these requirements is a prerequisite for placing the medical devices on the Europe market.

In comparison to the MDD, the MDR as a European regulation does not have to be implemented into national law first. It will therefore apply directly in Germany from May 26, 2021.

 

What are the objectives of the MDR?

The MDR is intended to


Implementation deadlines

Important note: All products placed on the market under the MDD by May 26, 2024 may be continued to be distributed until May 27, 2025 ("sell-off clause").
► Distributors may sell MDD-compliant products that have already been placed on the market for the first time until May 27, 2025. Products that have already been supplied to end users (e.g. dental laboratories) by the end of this transitional period can be used after this date.

MDR: What's new?

Will pritidenta's products continue to be available as of May 2021?

pritidenta has renewed its certificates under the MDD in 2019. They are valid until January 04, 2024, so all certified products may be placed on the market by us until that date. After that, the provided products that are still in your warehouses at that time may be sold until May 27, 2025.

How does pritidenta as a manufacturer ensure compliance with the MDR?

pritidenta is in the process of adapting its quality management system and technical documentation to meet the requirements of the MDR and has provided the necessary personnel and financial resources for this purpose. We will complete the certification of our products according to MDR on time, so that the delivery of our products is ensured at all times.

Our Notified body, mdc medical certification GmbH, has already received the official designation under Regulation (EU) 2017/745 (MDR) on April 25, 2020 and therefore fully complies with the requirements of the MDR.

What does the MDR require from you as a distributor distributor obligations)?

If you are a customer of pritidenta and sell our products, you always assume the role of a distributor. Under the MDR new obligations will arise for you, about which we would like to inform you.

The following obligations apply to you as long as the product is in your area of responsibility. If you have reason to believe that a product does not meet the requirements of the MDR, you are not allowed to make this product available on the market.

Examination of the product and the documents before making them available on the market

These inspection obligations can be covered by a sample inspection.

Ensuring the storage and transport conditions

Participation in market surveillance

Ensuring traceability

What information does pritidenta provide relating to the MDR?

You can request or download the following information:

Where can you find more information?


Any questions?

If you need help or more information - we will be pleased to help you. Just send your questions to quality[at]pritidenta.com - we will contact you as soon as possible.

Regulation

The MDR is an EU regulation. EU regulations apply directly in the
member states of the EU and do not first have to be transposed into national law.
They are binding in all their parts. Adjustments by individual member states are generally not possible.

However, regulations can also contain individual articles that permit adaptations to national law.
In Germany, the Medical Device Law Implementation Act (MPDG) serves to implement and complement the MDR.

Directive

The MDD is an EU directive. EU directives are not directly effective in European law, but must
first be converted into national law by the EU member states. In Germany, for example, the
MDD was implemented by the Medical Devices Act (MPG).

Economic operator

The term "economic operator" was newly added to the MDR. Economic operators are
entities within the supply chain of a medical device. The MDR recognizes the following
economic operators:

  •  Manufacturer
  •  Authorized representative
  •  Importer
  •  Distributor
  •  Distributor of systems or procedure packs

The MDR defines certain responsibilities and obligations for each economic operator.
The main obligations for manufacturers are regulated in Artikel 10 der MDR of the MDR. Artikel 14 MDR MDR defines the general obligations for distributors.

Placing on the market

According to the MDR, the first time a product is made available (i.e., supplied against payment or free of charge for distribution, consumption or use in the course of a commercial activity) on the EU market.

Example: A European manufacturer sells his product to a European distributor for the first time. The manufacturer thereby places the product on the market and at the same time makes it available. When the distributor resells the product, he makes it available.

Manufacturer

A manufacturer markets a product under his name or brand. It makes no difference whether he manufactures it himself or has it manufactured.

Distributor

A distributor makes a product available on the market after it has been placed on the market by the manufacturer oder Importeur in Verkehr or importer. The general obligations of distributors are regulated in Artikel 14 of the MDR.

EUDAMED (European Database on Medical Devices)

The European Database on Medical Devices is the IT-system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices. EUDAMED is intended to improve the transparency and coordination of information on medical devices available in the EU market.

The system is intended to function as a registration system, a cooperation system, a reporting system, a dissemination system (partially accessible to the public) and to be interoperable.

It consists of 6 modules (1. Actor registration, 2. Unique Device Identification (UDI), 3. Certificate, 4. Clinical investigation, 5. Vigilance, 6. Market surveillance), of which only the Actor registration has been activated so far (since December 01, 2020).

Manufacturers, importers and authorized representatives have to register in EUDAMED according to MDR. No registration is foreseen for distributors.

Technical Documentation

The Technical documentation for medical devices includes all documents that manufacturers must provide in order to have their medical devices subjected to a conformity assessment and to be allowed to place medical devices on the market. The structure and content are specified in detail in the MDR.

Labeling

Written, printed, or graphically represented information placed either on the product itself or on the packaging of each unit or on the packaging of multiple products.

UDI („Unique Device Identification“):

The UDI is a globally unique product identification number for medical devices. It must be applied to the product or its packaging in machine-readable form (e.g. barcode) and in plain text.

pritidenta already applies the UDI to the labels of its packaging and thus fulfills the new MDR requirements.

Example of an UDI on pritidenta's packaging

Classification

Medical devices in Europe are classified into 4 different risk classes (I, IIa, IIb, III) based on their intended purpose. The classification rules are defined in Annex VIII of the MDR.

Notified body

Notified bodies in the EU are government-appointed and government-monitored private auditing and certification bodies that act on behalf of manufacturers to accompany and monitor their conformity assessment for their products. In order to be able to operate under the MDR, the Notified Bodies for medical devices must pass an extensive inspection procedure before they are "re-designated".

Incident

An incident according to the MDR means a malfunction or deterioration in the characteristics or performance of a device already made available on the market, including use-errors due to ergonomic features, as well as an inadequacy of the information provided by the manufacturer or an undesirable side-effect.

Symbol „MD“

REF 292 Rev 000