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Conformity Assessment Routes

Depending on the product classification, your company may need to trade-off the conformity assessment routes.  For example, the route with the highest degree of effort involves the preparation of a design dossier and implementing an ISO 9001 / ISO 13485 quality system.  However, most of the quality system requirements are now included in the USA QSr, the Quality System regulation.  Further, a design dossier includes many of the same information as a 510k.  You can refer to the chart below to start evaluating your conformity route choices:

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 9001 / 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.