Conformity Assessment Procedures under MDR FAQ
Q: What is the process for demonstrating conformity of class I devices?
A: To demonstrate the conformity of class I devices, manufacturers need to draw up the Technical Documentation according to Annexes II and III and issue an EU Declaration of Conformity (DoC).
Q: Are there any specific requirements for certain types of class I devices?
A: Yes, for devices that are placed on the market in a sterile condition, have a measuring function, or are reusable surgical instruments, manufacturers shall apply the conformity assessment procedure based on a quality management system and on assessment of Technical Documentation explained in Chapters I and II of Annex IX, or conformity assessment based on product conformity verification according to Part A of Annex XI.
Q: What is the role of notified bodies in the case of class I devices?
A: In the case of class I devices, the role of notified bodies is limited to certain aspects, as specified in Article 52(7).
Q: What is the conformity assessment process for Class IIa devices?
A: Class IIa devices undergo a conformity assessment based on a quality management system, as specified in Annex IX, Chapters I and II. Additionally, an assessment of Technical Documentation (Annex IX, Chapter II, Section 4) is required for at least one representative device in each category of devices, as stated in Article 52(6).
Q: Is there an alternative option for conformity assessment for Class IIa devices?
A: Yes, manufacturers of Class IIa devices have an alternative option. They can choose to draw up the Technical Documentation according to Annexes II and III and opt for a conformity assessment based on production quality assurance and product verification. This alternative is detailed in Sections 10 and 18 of Annex XI. Similar to the previous method, the assessment of the Technical Documentation is required for at least one representative device in each category of devices, as specified in Article 52(7).
Q: What is the conformity assessment process for Class IIb devices?
A: Class IIb devices undergo a conformity assessment based on a quality management system, as specified in Annex IX, Chapters I and III. Additionally, an assessment of the Technical Documentation (Annex IX, Chapter II, Section 4) is required for at least one representative device per generic device group.
Q: Are there any specific requirements for Class IIb implantable devices?
A: Yes, for Class IIb implantable devices (excluding sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors), the assessment of the Technical Documentation according to Annex IX, Chapter II, Section 4 is required for every device.
Q: What is the conformity assessment process for Class III devices and Class IIb devices as defined in Article 52(4)?
A: Class III devices and Class IIb devices as defined in Article 52(4) undergo a conformity assessment according to Annex IX. This assessment is based on a quality management system and an evaluation of the Technical Documentation related to the specific device that the manufacturer intends to place on the market or put into service. The Technical Documentation must be in accordance with the requirements of the quality management system.
Q: Is there an alternative option for conformity assessment for these devices?
A: Yes, the manufacturer may choose an alternative option. They can apply for a conformity assessment based on type examination as specified in Annex X, coupled with a conformity assessment based on product conformity verification as specified in Annex XI.
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