Medical Devices Regulation Intended Benefits of the new CE Marking Regime

I. Context

MedTech Europe has always supported the goals of the Medical Devices Regulation 2017/745 (‘the MDR’), namely: to create a robust, transparent, predictable and sustainable regulatory framework that:

  • Delivers a high level of safety and health whilst supporting innovation,
  • Ensures the smooth functioning of the EU internal market for medical devices, and
  • Takes into account the great many small and medium-sized enterprises that are active in this sector.

Since 2019, more and more medical devices have been steadily CE marked under the MDR and then placed on the European Union (EU) market.

For this reason, interested parties may find this document to be a useful informational reminder of the benefits the new CE marking is intended to represent and deliver.

The MDR regulatory system comes with a lot of benefits for all the healthcare stakeholders, including patients, health institutions, health authorities and industry. MedTech Europe therefore calls to address the structural issue of Notified Bodies which is putting pressure on the MDR transition deadline.

These benefits are described in MedTech Europe’s own words, though taking strong inspiration from existing language used by the EU Commission[1] since 2017, when the MDR was first adopted and published.

When reading this document, please note that:

  • Due to the several hundreds of thousands of medical devices that exist in the EU, and the limited certification capacity that presently exists in the EU regulatory system, it is expected that additional years before all medical devices will be successfully CE marked under the MDR, and
  • Before the final regulatory deadlines have past for the transition of existing medical devices to the MDR, products CE marked under the Regulation and products CE marked under the former Directives (that the MDR is replacing) will co-exist on the EU market, and both will have equal status under the law provided that the applicable CE marking rules have been followed.

As a result, eligibility criteria in public tenders may not discriminate between these two categories of medical devices during this transitional phase.

II. Benefits of the MDR CE marking, when lawfully affixed to medical devices

The MDR strengthens the CE marking regime for medical devices in various ways, e.g., in the areas of:

Patient safety

Medical devices CE marked under the MDR are compliant with stricter patient safety requirements, and stricter controls to verify that those requirements are met. At present, these requirements and controls are quite possibly the strictest that exist anywhere in the world.

Quotations from Published EU Commission Factsheets

The new rules introduce better protection of public health and patient safety.”

“The new rules significantly tighten the controls to ensure that medical devices are safe and effective. The new rules also better reflect the most recent scientific and technological progress and set the gold standard for medical device regulation globally.”

Clinical evidence

Compliance with the MDR’s strengthened safety and performance requirements must in general be demonstrated via clinical evidence, where appropriate.  Clinical investigations conducted in Europe to generate this clinical evidence are also subject to modernised and more detailed requirements.  For certain high-risk devices CE marked under the MDR, independent expert panels also scrutinise the assessments conducted on the manufacturer’s clinical evaluation, e.g., to verify that the claimed levels of safety and performance are substantiated.

Quotations from Published EU Commission Factsheets

Rules on clinical evaluation and clinical investigation are generally strengthened.”


Various information on medical devices CE marked under the MDR must in the future be registered and publicly accessible/transparent, via a new European database currently under construction. This public information will grant interested parties – such as patients, healthcare professionals, health institutions, procurers, citizens and so on – better oversight into medical devices on the market, the companies that manufacture or import them, and so on.  Most implants CE marked under the MDR must also be provided together with a new implant card, containing information designed to better inform and empower patients, no matter where in the EU they are implanted.

Quotations from Published EU Commission Factsheets

The Regulations increase transparency, requiring the publication of information on devices and on clinical and performance studies related to their conformity.”

“The new Regulations pave the way to a more patient-friendly environment, where transparency and patients’ information and choice are a priority; where patients can benefit from innovative, highly performing devices and new therapies become possible.”

“An ‘implant card’ for patients containing information about implanted medical devices that will make information easily available and accessible to the particular patient.”


Medical devices CE marked under the MDR must have unique device identifiers assigned to them and – by the applicable deadlines – affixed to them and to their various packaging layers.  This Unique Device Identification (UDI) system is implemented to enable and enhance traceability of medical devices in the supply chain, at least until they reach the health institution for which they are intended.  This in turn is hoped to strengthen safety monitoring of devices placed on the market, and to combat device counterfeiting/falsification and reduce medical errors.

Quotations from Published EU Commission Factsheets

“A new Unique Device Identification (UDI) system…greatly enhances the traceability and the effectiveness of post-market activities related to safety.”

“The UDI will be a barcode, a QR code or any other machine-readable code. This will enhance the identification and traceability of devices and the effectiveness of post-market safety-related activities through targeted field safety corrective actions and better monitoring by competent authorities.

“UDI should also help to reduce medical errors and fight against falsified devices.

“Use of the UDI system should also improve purchasing, waste disposal and stock management by health institutions and other economic operators”


Medical devices CE marked under the MDR must be accompanied by more extensive labelling, intended to benefit device users.  The enlarged labelling requirements identify, in more granular ways, what the device is, where the instructions for use can be located, plus additional information such as whether hazardous or medicinal substances are present in the device.

Quotations from Published EU Commission Factsheets

“The Regulations improve labelling. New requirements aim to make it easier to identify products, find instructions for use, and get information about the safety and performance of devices. For example, labels will contain new information, along with symbols showing the presence of hazardous or medicinal substances.”


Medical devices may only be CE marked under the MDR if manufacturers have ensured sufficient financial coverage, e.g., to compensate patients for harm they may encounter when exposed to defective products for which the manufacturer is potentially liable.

Quotations from Published EU Commission Factsheets

“A robust financial mechanism to ensure patients are compensated in case they receive defective products. The Regulations require manufacturers to have measures in place to provide sufficient financial coverage in respect of their potential liability.”


[1] For instance, refer to EU Commission factsheets.  Examples here, here and here.




About MedTech Europe

MedTech Europe is the European trade association for the medical technology industry including diagnostics, medical devices and digital health. Our members are national, European and multinational companies as well as a network of national medical technology associations that research, develop, manufacture, distribute and supply health-related technologies, services and solutions.


For more information, please contact: 

Oliver Bisazza

Director General – Industrial Policies & External Affairs

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Jessica Imbert

Director – External Affairs

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For media enquiries, please contact:

Caroline Moulins

Senior Manager Communications

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