EU MDR 2017/745: FAQ
- Arlette Schilter
- 1 day ago
- 2 min read
EU MDR 2017/745 is a regulation of the European Union concerning medical devices. It repeals Directive 93/42/EEC on medical devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
What does the EU MDR 2017/745 regulate for medical devices?
"This Regulation lays down rules concerning the placing on the market, making available on the market, and putting into service of medical devices for human use and accessories for such devices in the Union. It also applies to clinical investigations concerning such medical devices and accessories conducted in the Union."
This is the first paragraph of Article 1 – Subject matter and scope.The full Article 1 describes in detail what must be taken into account.
Where can I find the consolidated version of EU MDR 2017/745 in English?
Here is the official link.
Where can I find the consolidated version of the MDR in German?
Here is the official link in German.
Why must EU MDR 2017/745 be followed?
The Medical Device Regulation (MDR) is a binding regulation for all manufacturers who intend to place medical devices on the European market.
It also applies to distributors, importers, and notified bodies involved in the regulatory process.
What are medical devices under the EU MDR?
Medical devices are products with a medical purpose, intended by the manufacturer for use on humans.
This includes implants, products for injection, infusion, transfusion and dialysis, medical instruments, software, catheters, pacemakers, dental devices, wound dressings, vision aids, X-ray machines, condoms, surgical instruments, in vitro diagnostics, and products for contraception.Source: German Federal Ministry of Health
For which countries does the EU MDR 2017/745 apply?
The MDR applies to all EU member states and to certain associated countries that adopt EU legislation in specific areas.
Specifically, it applies to:
✅ All EU member states (e.g., Germany, France, Italy, etc.)
✅ EEA/EFTA countries that have adopted the MDR, including:
Norway
Iceland
Liechtenstein
✅ Switzerland: Switzerland has not fully adopted the MDR since the Mutual Recognition Agreement (MRA) with the EU was not updated after May 2021. Nevertheless, non-EU manufacturers selling to Switzerland must meet comparable requirements (e.g., via a Swiss Authorised Representative or CH-REP).
✅ Turkey: Turkey has partially adopted the MDR due to its participation in the customs union with the EU. Full alignment with the MDR is planned.
What are the most important updates in EU MDR 2017/745?
10x more content than previous directives
Stricter clinical evaluation requirements
European UDI (Unique Device Identification) system
EUDAMED database
Extended post-market surveillance with reporting obligations
New classification rules
New roles such as “Authorised Representative”
Changes to labeling requirements
Detailed technical documentation
New GSPR (General Safety and Performance Requirements) Matrix
What is the current status of harmonized standards under EU MDR 2017/745?
Does the EU AI Act also apply to medical devices?
What changes have been made to EU MDR 2017/745 since 2017?
What do I need to know about compliant labeling under EU MDR 2017/745?
The MDR is a long and complex document with many overlapping areas.To implement it efficiently, a systematic interpretation is essential.That’s exactly what ColabON provides.
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