Increase in Requirements
Conformity Assessment assessment routes under MDR 2017/745 have not significantly changed under MDR 2017/745 compared to MDD 93/42/EEC however, the timeline to CE marking might now be longer, particularly if there is involvement of expert bodies e.g the MDCG (Medical device co-ordination group). The number of requirements of GSPR’s (Annex I- General Safety and Performance requirements) has increased under MDR compared to the number of Essential Requirements under MDD. Common specifications requirements have also been introduced for some devices. Medical Devices are required to be in compliance with the relevant GSPRS (Annex I). Compliance with EN harmonised standards and Common specifications (CS) presumes compliance with the GSPR’s.Summary of Conformity assessment routes under MDR 2017/745:
Class I
For Class I devices (with the exception of Class Im (measuring), Class Is (sterile) and Class Ir (reusable)), the ‘self-certification’ route is acceptable with a requirement to maintain Technical documentation according to Annex II and Annex III. However, for Class Im, Class Is and Class Ir, a limited QMS (Quality Management system) must be in place to control the production (Annex XI Part A) or to control the special characteristics (Annex IX Chapter I). The involvement of an NB (Notified Body) is required to assess this QMSClass IIa
Class IIa devices may undergo conformity assessment under Annex IX (Full QMS) or undergo assessment under Annex XI (Production Control) together with Technical documentation as per Annex II and III. Conformity assessment under Annex IX (Full QMS) requires an NB audit of QMS and NB assessment of the Technical Documentation/Design Dossier. Conformity assessment under Annex IX requires an NB audit of Production Quality Assurance for the ability to produce and test the device.Class IIb
Class IIb devices categories are- Class IIb implantable
- Class IIb active device intended to remove or administer medicinal substances
- Class IIb devices not included as any of the above.
- Class IIb implantable – Annex IX Chapter I (QMS) and Section 4 (Technical documentation for every device without expert review)
- Class IIb non-implantable – Annex IX Chapter I (QMS) and Section 4 (Technical documentation for representative device without expert review)
- Annex X (Assessment based on Type-Examination) and Annex XI-Part A (Production Quality Assurance)
- Annex X (Assessment based on Type-Examination) and Annex XI-Part B (Product verification)
- Annex IX Chapter I (QMS) and Section 4 (Technical documentation for every device with expert review)
- Annex X (Assessment based on Type-Examination) and Annex XI-Part A (Production Quality Assurance)
- Annex X (Assessment based on Type-Examination) and Annex XI-Part B (Product verification)
Class III
For Class III devices the following Conformity assessment routes may be used:- Annex IX (Assessment based on a QMS and assessment of full Technical documentation)
- Annex X (Assessment based on Type-Examination) and Annex XI-Part A (Production Quality Assurance)