2. Notified Bodies and Conformity assessment
Notified Bodies and Conformity assessment
Manufacturers need to demonstrate that the Medical Device meets the requirements in the MDR or IVDR to ensure they are safe and perform as intended by carrying out a conformity assessment. The assessment route depends on the classification of the device. The risk class determines whether or not a conformity assessment done by a Notified Body would be required.
EU Member States designate, accredit, and monitor/supervise conformity assessment bodies, called ‘Notified Bodies’,  (according to Chapter IV Notified Bodies, Arts. 35-50 of the MDR) to conduct conformity assessments where applicable. Notified Bodies are independent certification bodies. They perform third-party conformity assessment activities including calibration, testing, certification and inspection. The Conformity assessment usually involves an audit of the manufacturer's quality management system and, depending on the device, a review of technical documentation from the manufacturer on the safety and performance of the device.
Thus, typical tasks of Notified Bodies include:
- Certifying quality management systems according to the Annexes of MDR
- Reviewing technical files such as risk management files, software files and usability files, and checking compliance with legal requirements
- Assessing clinical evaluations
Manufacturers can certify their products with any Notified Body within the EU.
Conformity assessment and approval by a Notified Body is required for Class IIa, IIb and III Medical Devices and Class B, C and D in vitro diagnostic devices.
A Notified Body does not have to be involved in the Conformity assessment procedure for class I Medical Devices or class A in vitro diagnostic devices. However, some Class I (“class I* devices”) and Class A devices will require Notified Body approval for parts of the manufacturing process if they are sterile, have a measuring function or are reusable surgical instruments .
For both, Medical Devices and IVDs and irrespective of the class, a number of requirements must be fulfilled for a Conformity assessment.
- Benefits must outweigh risks and achieve the claimed performance - This must be proven with supporting clinical evidence and investigation(s) where necessary;
- Design and manufacture requirements;
- Performance characteristics for in vitro diagnostic Medical Devices;
- Information supplied by the manufacturer with the device - For example, instructions for use, correct labelling.
2. Technical documentation (Annex II of the MDR and IVDR)
3. Harmonised standards / common specifications (Articles 8 and 9 of the MDR and IVDR)
Further, more detailed information can be found in Annex IX, X and XI of the MDR and the IVDR.
In certain circumstances, a Competent Authority may authorise the placing on the market or putting into service a specific device that has not carried out a Conformity assessment procedure as referred to in Article 52 of the MDR or Article 48 of the IVDR.
This can happen in circumstances that are in the interest of public health or patient safety or health (Article 59 of the MDR and Article 54 of the IVDR).
 MDCG: “Guidance Notes For Manufacturers of Class I Medical Devices” https://ec.europa.eu/health/system/files/2020-07/md_guidance-manufacturers_en_0.pdf