Medical Device Regulation EU

CE Mark for Medical Devices on labels and packing proves that device(s) meet the current EU medical device regulation or medical device manufacturer’s claim that a product meets the General Safety requirements of European Regulation.

The Regulation outline the safety and performance requirements for medical devices in the European Union (EU).CE Mark for Medical Devices is a legal requirement to sell a device in European Union countries.

Before affixing Medical Device CE Marking, the device must follow the definition and be classified correctly following the classification rules laid down in annexes VIII of the EU MDR 2017/745. Medical devices are divided into four risk classes: I (Im, Is), IIa, IIb and III. Class, I medical devices are lower risk devices, while class III medical devise are the highest risk devices.

The manufacturer of a class I device is responsible for the self-declaration of the MDR CE marking process. A notified body must certify medical devices belonging to higher risk classes.

The Medical Device Regulation EU is a new set of regulations that govern medical devices’ production and distribution in Europe. Compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace.

The EU MDR regulation is intended to improve the safety and performance of medical devices in Europe and, as such, intends to provide a high level of protection for the health of patients and users of these medical devices.

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1. The new regulation is four times longer, comprehensive and contains five more annexes than its Medical Device Directive (MDD).
2. Significant changes in wording used in the new law will require companies to rationalize their portfolios and perform a global impact assessment to implement the necessary changes to remain compliant.
3. Annex I, General Safety and Performance Requirements, identifies new conditions that will need to be addressed for most legacy devices (CE marked under the MDD). Existing products must be re-certified following the new regulations within the stipulated time.
4. The new rules will require most companies to update clinical data, technical documentation, and labelling.
5. Unique Device Identification (UDI) will help track devices throughout the economic operator supply chain and will be required on all labels.
6. The definition of medical devices will be broadened to include non-medical and cosmetic devices not previously regulated. Examples include products for cleaning, disinfection or sterilization of devices, contact lenses, liposuction equipment, or epilation lasers.
7. Manufacturers will need to generate and provide more in-depth clinical data to prove safety and performance claims, including tighter equivalency standards.
8. Manufacturers will need to report all incidents, injuries and deaths into an EU portal that will centralize relevant data so that patients have access to more safety-related information. Reporting for incidents that did not result in death or serious deterioration in health is moved to 15 days from 30 days.
9. Companies undergoing transition will need to revisit core processes, including quality assurance, risk management, and post-market expectations. These will require careful review, planning and updating to re-implement with new requirements.
10. Reclassification of many medical devices to a higher risk class and a new classification for reusable surgical devices requiring notified body intervention.

Technical File as per Annex II of EU MDR 2017/745 is a technical document prepared by the manufacturer in a clear, well-organized, and unambiguous manner to demonstrate the general safety and performance of the device in question. The MDR Technical File for Medical Device of Higher class require notified body intervention or submitted to Competent Authority for review and approval.

This technical file should be preferably made in English or an official language of an EU Member state. In addition, for the Class I Medical device, a technical file must be prepared for self-declaration of CE mark over labels.

It must be available on request for the whole life cycle of the medical device (5 years for low risk and 16 years for high-risk devices) until and unless there is a change in device design. Non-EU manufacturers shall share the technical file with the authorized representative in the EU.

The technical documentation is prepared to demonstrate the conformity to the Medical device’s general safety and performance requirements as per European Union Medical Device Regulation 2017/745. It includes the device design and development, clinical evaluation and performance validation, conformity assessment and regulatory status within target markets.

Furthermore, the MDR now requires a closed-loop process, implemented with data from the post-market use of the device (PMS), to ensure that early warnings are captured, and the ‘General Safety and Performance Requirements (GSPRs) are continuously fulfilled that the benefits for the patient always outweigh the risks.