EU MDR – Guide overview
Below is a summary of different activities pertaining to the EU MDR (Europe Medical Device Regulation 2017/745). Compliance with EU MDR requirements will be mandatory starting from May 26, 2021. Our summary includes the following sections:
- Summary of obligations from the manufacturer
- Summary of obligations of the manufacturer concerning his devices before they are placed on the market
- Summary of obligations of the manufacturer concerning his devices after being placed on the market
For each section below you may click on it to get more details about each activity.
Summary of EU MDR obligations from the manufacturer
Have at least one person responsible for compliance with regulations.
Art. 15 of EU medical device regulation
In the case of the manufacturer established outside the EU:
Appoint a representative established in the EU territory, responsible to perform certain tasks on his behalf and under his mandate.
Have sufficient financial cover in case of responsibility for defective products.
Art. 10, 16)
Have a quality management system that guarantees compliance with the provisions of the Regulation.
Art. 10, 9)
Regulatory requirements monitoring
Put in place a regulatory monitoring process at the European level.
Art. 8, 9 and 10 Annex I 1
Have an archiving system for documentation, techniques, declarations of conformity, and certificates compliance of its devices.
Art. 10, 8)
Respect the obligation of confidentiality concerning its information and data obtained in the execution of his tasks and in particular:
- the personal data,
- confidential information of a commercial nature and business secrets, including property rights intellectual property, unless the public interest justifies disclosure,
- the application of the Regulation, in particular as regards inspections, investigations, or audits.
Cooperate with the competent authorities who can ask the manufacturer for documentation, information, samples, or access to a device, or perform inspections on its premises, those of its suppliers and its subcontractors.
The manufacturer must also cooperate with the notified body which assesses or has assessed the conformity of its device, and provide it, on request, any information, document, access (to its premises, its suppliers and subcontractors) the notified body would need to fulfill his mission.
Art. 93, 3) Annexes VII, IX, and XI
Summary of obligations of the manufacturer concerning his devices before they are placed on the market in EU MDR
Certain EU MDR requirements apply to the devices before placing them on the market. In most cases, they can be addressed during the design and development activities. EU medical device regulation defines several categories of requirements.
Define in particular the indication and the intended use of the device, its characteristics, its mode of action, and deduce his risk class.
Art. 51, Annex VIII of EU medical device regulation
Design a device that meets general requirements in terms of security and performance. Conformity with applicable harmonized standards or common specifications presumes conformity with the requirements covered by those standards or specifications.
Art. 8, 9 and 10, 1) Annex I
Provide risk management for the entire life cycle of the device.
Art. 10, 2) Annex I 3
Manufacturing and validation of the device
Validate the manufacturing process and guarantee production in series in accordance with the requirements of the Regulation.
Art. 10, 9)
Perform a clinical evaluation to demonstrate the conformity of the device with the general safety and performance requirements, to evaluate the effects, and to decide on the benefit/risk ratio.
Art. 5, 3) and 61
Information provided by the manufacturer
Assign a UDI to each of its devices and affix it on the label and all levels of packaging (except transport packaging). The UDI must be affixed on the device itself when it is reusable.
The manufacturer must register the UDI of each device in the UDI database:
- before the conformity assessment request for the MDs Class III and Implantable Class II MDs
- before placing on the market for other DMs
Label and instructions for use
Accompany his device with a label and, where appropriate, of a notice, which complies with the 2017/745 Regulation. This information is provided in the accepted languages in the Member States in which the manufacturer wishes to sell the device.
Annex I 23
Media and communications accessible to the user or to the patient (labeling, notice, advertising medium) must not contain any element likely to mislead them with regards to the intended purpose, safety, and performance of the device.
For class III devices and implantable devices: prepare a summary of the safety and clinical performance of the devices.
For implantable devices:
- provide with each device information allowing to identify the device and the manufacturer, information safety and the lifetime of the device and the materials and substances to which patients are likely to be exposed,
- provide information to identify the manufacturer and the device in the form of a delivery implant card to the patient.
Technical Documentation in EU MDR
Develop and maintain technical documentation for each of the manufacturer’s devices.
Art. 10, 4)
Evaluation of conformity
Before placing a device on the market, assess its conformity according to the applicable procedures. Then draw up an EU declaration of conformity and affix CE marking.
Art. 52 Art. 19 and 20
Registration in Eudamed
Register as a manufacturer, if it has not already done so, before the first submission of an application for evaluation of conformity with a notified body or before the first placing on the market of a device. The manufacturer then gets a unique registration number.
Register each device that it puts on the European Union market or for which it submits an application for a notified body (through the basic UDI-ID).
Summary of obligations of the manufacturer concerning his devices after being placed on the market in EU MDR
Once the device is on the market it doesn’t mean the obligations from the manufacturer stop. The EU MDR also includes requirements regarding post-market surveillance.
Be able to identify any economic operator to whom he directly provided a device, which directly provided him a device, and any institution or health professional to which he directly provided a device.
Art. 25, 2)
Maintain a list of all UDIs he has assigned.
Art. 27, 7)
Save and record, preferably electronically, the UDI of the class III devices that he provided or that he’s been provided.
Art. 27, 8)
Have a post-market surveillance system. This system is based on a surveillance plan after putting on the market which is detailed in the technical file of the device.
Art. 83 and 84
Collect data on quality, performance, and the safety of his medical devices throughout their lifetime.
Prepare a Report on post-market surveillance (for Class I devices) and a periodic safety update report – PSUR (for its class devices IIa, IIb, and III). These reports must be updated according to a periodicity defined in the Regulation.
Art. 85 and 86
Have an incident recording and reporting system and field safety corrective actions.
Notify these incidents to the relevant authorities via Eudamed, according to deadlines taking into account their severity.
Art. 10, 13) and 87
The manufacturer must send to the competent authorities via Eudamed any statistically significant increase in the frequency or severity of certain incidents that could have a significant impact on the benefit/risk ratio of the device in a trend report.
Carry out the necessary investigations following the notification of serious incident and report to the authorities competent authorities via Eudamed.
The report sent by the manufacturer to the competent authorities following the notification of a serious incident must indicate the corrective measures to be taken.
Take corrective action immediately to comply with a non-compliant device, withdraw it or recall it, and inform the economic operators concerned.
Art. 10, 12)