EU regulations for medical devices and in-vitro diagnostics – Medical Device Regulations
The EU Medical Device Regulations (MDR and IVDR) have come into force and have fundamentally changed the regulatory environment for medical devices in the EU.
The MDR and IVDR were adopted on April 5, 2017 and have been fully applicable since May 26, 2021 and May 26, 2022 respectively. The original transition periods were extended due to the complexity of the new regulations and the COVID-19 pandemic.
Current situation:
- Transitional provisions apply to medical devices that were first placed on the market before May 26, 2021 (depending on the risk class according to the new regulations):
Medical devices (MDR) until the end of 2028 at the latest
In-vitro diagnostics (IVDR) until the end of 2029 at the latest - For medical devices placed on the market for the first time after May 26, 2021 (risk class I (MDR) or A (IVDR), new or significantly modified devices):
These medical devices must fully comply with the requirements of the MDR or IVDR as of May 26, 2021.
Key points:
- Greater patient and consumer safety: The new regulations place a greater focus on the safety and performance of medical devices.
- Increased requirements for manufacturers: Manufacturers must fulfill more comprehensive conformity requirements (e.g. PMS, clinical data, UDI,…) and update or introduce quality management system processes (MDR or IVDR).
- New labeling requirements: Unique Device Identification (UDI) is a key component of the new regulations and enables better traceability of medical devices.
Note: The exact transition periods and requirements vary depending on the product type and class. It is strongly recommended that you contact an expert or the responsible authority for specific questions. We will be happy to help you individually!
More information on the transition periods
The following are affected:
- Active implantable medical devices
- Medical devices
- In vitro diagnostics
Resources:
The “Medical Devices Regulations” published in the Official Journal of the European Union:
Here you will find helpful information:
- MDCG guidelines to support the implementation of the requirements
On this page you will find a series of documents to support stakeholders in the application of the MDR and IVDR. Most of the documents on this page are endorsed by the Medical Device Coordination Group (MDCG) in accordance with Article 105 of the MDR and Article 99 of the IVDR. They are written in collaboration with interested parties represented in the various groups and are labeled with the following format: “MDCG Year Number Revision”. - Notified bodies for MDR
Current status of notified bodies according to MDR. - Notified bodies for IVDR
Current status of notified bodies according to IVDR. - Current survey of notified bodies on certifications and certification applications (MDR/IVDR)
Regularly updated survey of notified bodies on certifications and applications under the auspices of Gesundheit Österreich GmbH (GÖG) - International Medical Device Regulators Forum – Documents
The IMDRF supports with its work the global harmonization and convergence of regulatory requirements - European Commission – Medical Devices
Helpful information sheets on the MDR and IVDR regulations. - Medical Devices – New regulations – Fact Sheets
Fact sheets, infographics and step-by-step guides for specific classifications, product groups or economic operators on MDR and IVDR. - European Commission – Medical Devices -Topics of Interest
Information sorted by topic: e.g. harmonized standards, UDI, etc. - European Commission – Harmonized Standards | Medical-Devices
Overview of the Harmonized Standards for Medical Devices(Summary list as pdf document) - European Commission – Harmonized Standards | In-vitro Diagnostica
Overview of the Harmonized Standards for In-vitro Diagnostics(Summary list as pdf document) - EUDAMED database – EUDAMED
All information on the European database for medical devices(current status July 2025 – gradual introduction of modules with focus on functionality) - European Medical Device Nomenclature (EMDN)
Overview of the European Medical Device Nomenclature (EMDN), which is intended to support the functioning of the European Database for Medical Devices (EUDAMED). Among other things, it is used by manufacturers for the registration of medical devices in EUDAMED, where it is linked to each Unique Device Identifier (UDI-DI). - New and unique medical device glossary in Europe
The medical device glossary is a comprehensive, free document, unique in Europe, for practical work at manufacturers, as well as in politics and research. It includes a total of 219 abbreviations, a list of 763 terms with their definitions, from “medicinal product” to “intended purpose”. The comprehensive list of symbols contains 140 graphic symbols relevant for manufacturers when labeling, including explanations. All abbreviations, terms, definitions and symbols are listed and explained in German and English.
Our offer:
We support you with the following offers:
- en.co.tec Regulatory Kick-Start: Clarify individual questions relating to the In Vitro Diagnostics Ordinance and Medical Devices Ordinance
- en.co.tec Regulatory-Newsletter
- Current seminars on the Medical Devices and IVD Regulation
- Workshop: Conversion to the EU regulations MDR and IVDR → Gap analysis: Internal company workshop to discuss and plan the specific effects and measures.
We wish you every success in implementing the requirements and will be happy to support you!
DI Martin Schmid
Managing Director & Senior Consultant at en.co.tec
