2. How Medical Devices are placed on the market

How Medical Devices are placed on the market 

In the following the necessary steps to be taken before placing a Medical Device on the market are exemplary listed, based on and adapted from the guidance by the Medical Device Coordination Group (MDCG) (established according to Art. 103 of the MDR) [1] “Guidance Notes For Manufacturers of Class I Medical Devices”. While the exemplary steps given below apply to Class I Medical Devices, they apply in essence to other classes as well.

Following the integration of the MDR in the Quality Management System (QMS). 

1) Qualify product as a Medical Device

2) Confirm product Class

3) Procedures before placing on the market

a) Meet the general safety and performance requirements
b) Conduct clinical evaluation (with clinical investigation, when necessary)
c) Prepare technical documentation
d) Request Notified Body involvement where applicable (Classes I*, Class IIa, IIb and III medical devices and Class B, C and D in vitro diagnostic devices)
e) Prepare Instructions for Use and Labelling (Annex I, MDR)

f) Perform or pass conformity assessment

4) Check compliance with general obligations for manufacturers

5) Draw-up the EU Declaration of Conformity (Annex IV of the MDR and IVDR) in accordance with article 19 and article 52 (7) (translate this Declaration of Conformity into the national language of the country the device is placed on the market).

6) Affix the CE marking (Classes I*, Class IIa, IIb and III medical devices and Class B, C and D in vitro diagnostic devices after Notified Body certification).  

7) Registration of devices and manufacturers in the electronic system (Eudamed), including a Basic Unique Device Identifier (UDI-DI)

8) Post Market Surveillance (PMS)[1]

a) Review experience gained from Post-Market Surveillance

• • • PSURs - Periodic Safety Summary Report: Summarises the results and conclusions of the analyses of the post-market surveillance data. (Article 86 of the MDR and  Article 81 of the IVDR)
    • PMCF / PMPF - Post-Market Clinical / Performance Follow-Up: A continuous process that updates the clinical / performance evaluation. (Annex XIV, Part B of the MDR  and Annex XIII, Part B of the IVDR)
    • Other post-market studies

b) Vigilance. Key obligations:

• • • Reporting of serious incidents
    • Voluntary and mandatory reporting
    • Trend reporting
    • Conduct and report “Field Safety Corrective Actions” (FCSA)[2]

See Chapter VII, Section 2 of the MDR and IVDR for more information.

c) Non-conforming products. Apart from the reporting obligations mentioned above (step 8b), manufacturers must make appropriate corrections and/or take appropriate corrective action.

Reference: 

[1] Guidance Notes For Manufacturers of Class I Medical Devices. https://ec.europa.eu/health/system/files/2021-10/mdcg_2021-24_en_0.pdf