| Product Conformity Route |
Tradeoffs |
| Design Dossier Certification |
Preparation may be quite involved.
Learning curve if unfamiliar with process.No time limit for review and
certification or disapproval by Notified Body
Notified Bodies' learning curve maybe on your dossier
Dossier includes similar information to a 510k...opportunities for redundancy
elimination. |
| Registration File Approval IVDD Annex V |
Notified Body reviews a technical file for
conformity to harmonized standards FDA now has a 510k process which is
similar |
| Declaration of Conformity IVDD Annex III |
Self declaration without quality system audit or
product file review by Notified Body. Limited to low risk products not in
Annex II, self test, or for performance evaluation |
| Manufacturer's Statement |
Limited to products for performance evaluation in
clinical laboratories |
| Quality System Conformity Route |
Tradeoffs |
| ISO 9001 / ISO 13485 / IVDD Annex IV
Certification |
Includes formalized design controls with
verification and validation certification audit by Notified Body Similar
requirements to USA QSr (Quality System regulation 21 CFR 820) |
| ISO 9002 / IVDD Annex VII Certification |
Omits formalized design controls, includes
production quality system certification audit by Notified Body. Maybe
helpful to small companies desiring to launch in EU prior to USA. |
| EC Verification IVDD Annex VI |
Notified body inspects each batch of product for
conformity with essential requirements. Maybe helpful to small companies
or companies planning to release few batches into EU annually, or companies with great
difficulty establishing quality system. |
