Medical technologies are tightly regulated in the European Union. Before a medical technology can be legally placed on the EU market, a manufacturer must comply with the requirements of all applicable EU legislation and affix a CE mark to their device.
EU Regulations governing medical devices (MD) and in vitro diagnostic medical devices (IVD) were published in May 2017. MedTech Europe is working with our members and the authorities to support companies in complying with the legislation by the end of the extended transition periods.
How are medical technologies regulated today?
EU Directives have applied to medical devices (MD) and in vitro diagnostics (IVDs) since the 1990s. Two EU Regulations IVD Regulation 2017/746/EU (IVDR) and Medical Devices Regulation 2017/745/EU (MDR) were published in May 2017 governing the safety and performance of devices across their lifetime.
During a set of transition periods, manufacturers may choose to continue to comply with the applicable Directive or to opt for early compliance with the relevant Regulation.
Regardless of whether a product is CE-marked under the Directives or the new Regulations, customers will continue to use medical technologies with a high level of quality, safety and performance: the hallmark of the EU CE-marking system.
To ensure the availability of devices, the transition periods have been amended several times granting more time to companies to transition their legacy devices to the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) rules:
- Regulation 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions postponed the entry into application of Regulation (EU) 2017/745 (MDR) by one year until 26 May 2021.
- Regulation (EU) 2022/112 of the European Parliament and the Council of 25 January 2022 introduced a staggered extension of the transition periods provided for in Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) and deferred the application of conditions for in-house devices.
- Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.
- Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the information obligation to inform in case of interruption or discontinuation of supply, and the transitional provisions for certain in vitro diagnostic medical devices.
It is important to note that the above transitional periods apply for legacy devices: all new products need to be CE-marked under the IVDR and MDR (and comply with all applicable EU legislation) before they can be placed on the Union market.
Explore more content
MDR/IVDR Article 10a – A new bureaucratic challenge for manufacturers you may have missed
Posted on 10.01.2025
A vision for Europe’s medtech future: Safeguarding Europe’s access to medtech and innovation
Posted on 27.08.2024
The future of the Regulatory System: are we ready?
Posted on 29.03.2024
Key topics
-
Petra Zoellner
Director Regulatory Affairs (IVDR & MDR)
cC56b2VsbG5lckBtZWR0ZWNoZXVyb3BlLm9yZw==Petra Zoellner
Director Regulatory Affairs (IVDR & MDR)
Petra directs MedTech Europe’s team focusing on the implementation of the EU regulatory systems for medical devices and in vitro diagnostic medical devices. She represents MedTech Europe to external fora on strategic regulatory policy questions, including the Medical Devices Coordination Group. She also acts as part of MedTech Europe’s leadership team, ensuring collaboration and coherence on topics which cross over to other areas in the medical technology ecosystem.
Since Petra joined the association (previously EDMA, now MedTech Europe) in February 2012, her work has included leading and representing the association on regulatory policy in various domains including the implementation of the IVD Regulation, CE-marking topics, device labelling, trade in animal by-products, European database, medical technology standards, and regulation of substances and electronic devices, amongst others.
Before MedTech Europe, Petra worked for the American Chamber of Commerce to the EU (AmCham EU), where she headed up the policy team working on both legislative and regulatory issues. She also worked within the government affairs team of Genzyme. As an American-German national raised in Denmark who has lived many years in Belgium, Petra is a native English speaker with intermediate to good Dutch, Danish, German and French. Petra is married to a Belgian telecommunications engineer and has two young energetic sons.
Related content
Posted on 06.03.2025
Urgent call for clarity on clinical strategy discussions
Posted on 05.12.2024