A number of regulatory requirements must be taken into account when introducing medical devices into the European Union markets. The MDR was a significant update to the medical device legislation introduced in 2017. The MDR replaces the previous EU Medical Device Directive (MDD) and Directives 90/385/EEC on active implantable medical devices.. The EU MDR entered into force on May 25, 2017, with full application starting on May 26, 2021. What is this legal regulation, what does it refer to and how to comply with it? You will find the answers to these questions in this article.
What is EU MDR?
The EU MDR Regulation, officially known as Regulation (EU) 2017/745, is the European Union’s current legal framework for medical devices.
This regulation sets out the rules manufacturers must follow to place medical devices on the EU market. It covers everything from device classification and safety requirements to post-market surveillance and traceability.
The purpose of the EU MDR is to enhance patient safety, ensure clinical effectiveness, and increase transparency across the entire life cycle of a device. It was introduced in response to weaknesses identified in the previous regulatory system.
The EU MDR compliance process is significantly more complex than under previous directives. Manufacturers, especially those outside the EU, must work closely with an EU Authorized Representative to navigate the requirements successfully.
Where the EU MDR regulation applies?
Who needs to comply with EU MDR? The EU Medical Device Regulation (EU MDR) applies throughout the European Union (EU) and the European Economic Area (EEA) which includes Iceland, Liechtenstein, and Norway. Due to the Northern Ireland Protocol, it also applies in Northern Ireland, even after the UK’s withdrawal from the EU.
The regulation also applies to Notified Bodies, clinical investigators, and other economic operators involved in bringing a device to the EU market.
Manufacturers based outside the EU must consistently comply with all requirements, and they are required to appoint an Authorised Representative (AR) established in the EU/EEA.
Everyone in the supply chain must understand their responsibilities.
Read also: Distance sales devices: a look at EU requirements
Labelling of medical devices – requirements
Labelling is a core component of EU MDR compliance. Under Regulation (EU) 2017/745, the label must communicate essential information about the device’s identity, origin, safety, and usage. The goal is to protect patients and users by ensuring transparency and traceability across all EU markets.
Each medical device contained sufficient clinical evidence to demonstrate compliance, depending on the class of device.
The EU Medical Device Regulations (EU MDR) significantly expand labelling obligations compared to the Medical Device Directives (MDD and AIMDD). Key differences include:
- Mandatory UDI system for most devices, enhancing traceability and post-market surveillance
- Greater visibility of the Authorised Representative [SV1] [DK2] on the label
- Enhanced requirements for risk-related information, such as warnings and precautions
- Stricter oversight of label content and format, reviewed during the conformity assessment process
What are the biggest challenges to meeting MDR requirements?
Meeting the demands of the EU MDR Regulation is a complex process, especially for manufacturers unfamiliar with the updated framework. The regulation introduced significant changes that affect nearly every stage of a product’s lifecycle. Even experienced operators face challenges when transitioning from MDD to MDR.
One of the most substantial shifts under the EU MDR requirements is the level of technical documentation required.
Clinical data expectations are stricter. The MDR eliminates the option to rely on literature reviews or equivalence claims unless a direct technical, biological, and clinical comparison can be proven.
One major issue is the underestimation of the time and resources required to meet the MDR’s stringent requirements, leading to rushed documentation and incomplete clinical evaluations. To facilitate the transition, extra time has been given to “legacy devices”, with deadlines extended up to 2028, depending on the device’s class.
How to comply with the EU MDR? – Obelis
Achieving full EU MDR compliance is a multi-step process that requires strategic planning, in-depth regulatory knowledge, and strong documentation. For both EU-based and third-country manufacturers, the pathway to market starts with understanding the regulation’s demands and building a clear compliance roadmap.
As one of Europe’s most established regulatory service providers, Obelis offers a full suite of MDR compliance solutions. We offer:
- Acting as Authorised Representative (EAR or EC-REP)
- Ensuring the availability of technical documentation within the EU
- Verifying that the device meets MDR requirements
- Cooperating with authorities in case of inspections or incidents
- Registering devices in EUDAMED
- Supporting an experienced AR and representation in EU countries
- Application for FSC (Free Sales Certificate)
- Supporting the notified body’s application process
- Guidance on QMS (Quality Management System) requirements
- Acting as a legal representative for clinical investigations
With our support, you will learn exactly how to comply with the MDR EU directive.