Medical Device Industry
As a globally recognized notified body, TÜV NORD supports you in achieving MDR certification for your medical devices. We help ensure your products meet EU safety and quality standards, making them compliant and market-ready.
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The European Union Medical Device Regulation (EU MDR) – officially known as Regulation (EU) 2017/745 – establishes a unified framework for ensuring the safety, performance, and clinical effectiveness of medical devices marketed in the European Economic Area (EEA). It aims to strengthen patient protection, increase transparency, and improve post-market surveillance throughout the entire product lifecycle.
The MDR entered into force on 26 May 2017 and became fully applicable on 26 May 2021, replacing the Medical Device Directive (93/42/EEC) and the Active Implantable Medical Device Directive (90/385/EEC). Devices previously certified under MDD or AIMDD must undergo recertification to continue being marketed in the EU under MDR. For the latest version of the MDR you can request our MDR booklet including M5.
Even manufacturers with existing approvals must comply with the new, more rigorous MDR requirements – including updated clinical evidence, technical documentation, and risk management procedures.
Although transition periods for legacy devices have been extended through recent amendments, the timeline to achieve compliance is limited. Early action is essential to avoid market disruption.
As a designated Notified Body under EU MDR, TÜV NORD CERT GmbH provides expert certification services to help medical device manufacturers meet regulatory requirements and ensure continued access to the European market.
While MDR (EU) 2017/745 compliance is legally required for placing medical devices on the EU market, working with an experienced notified body like TÜV NORD delivers strategic advantages:
Includes certain non-medical products (e.g. aesthetic devices, dermal fillers, skin treatments). Annex XVI
Many devices are now classified in higher risk categories.
Article 51
Each manufacturer must appoint a qualified person for compliance oversight.
Article 15
Ongoing monitoring and clinical follow-up are now mandatory.
Articles 83–100
High-risk devices require updated clinical evaluations and public safety summaries.
Articles 61–80
All devices must be recertified under MDR — no automatic approval from old MDD/AIMDD.
Valid until 26 May 2024
New technical benchmarks for certain device categories.
Article 9
Traceability system with phased deadlines by risk class (2021–2025).
Article 27
The MDR booklet contains the consolidated version of Regulation (EU) 2017/745 on medical devices, also known as the Medical Device Regulation (MDR). The MDR has been mandatory since May 26, 2021. The MDR replaced both the Medical Devices Directive (MDD) 93/42/EEC and the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC.
Is your company ready for MDR certification? This MDR readiness checklist is designed to help manufacturers assess their current documentation, processes, and organizational setup before applying for certification under the EU Medical Device Regulation (EU) 2017/745.
The EU Medical Device Regulation (MDR – Regulation (EU) 2017/745) entered into force on 26 May 2017 and became fully applicable on 26 May 2021, replacing the former Medical Device Directive (MDD 93/42/EEC) and Active Implantable Medical Device Directive (AIMDD 90/385/EEC).
Transition deadlines have been extended for various reasons to support continued access to medical care in the EU.
MDR was introduced to strengthen patient safety and improve the transparency of medical device regulation across the EU. It addresses weaknesses in the previous system by introducing stricter clinical evaluation, post-market surveillance, and traceability through UDI (Unique Device Identification). MDR also expands the scope to include more types of products and ensures a higher standard of quality for devices marketed in Europe.
All devices previously covered under MDD and AIMDD remain regulated under MDR. However, new classifications and product groups have been added, including:
- Reusable surgical instruments – now classified under Class I (reusable surgical) and require Notified Body involvement for aspects like cleaning, sterilization, and reprocessing.
- Non-medical products listed in Annex XVI of the MDR
If your device does not have a valid MDR certificate (or extended MDD certificate under the transitional rules), it cannot be legally placed or made available on the EU market.
Our Project Management Circle is a global network of experienced project managers supporting healthcare and medical device organizations. Find out how PMC can help you streamline your processes.