Quality System Documentation (QSD) For EU Manufacturing Site

Abbreviated Application Modes for Quality System Documentation (QSD) Conformity Assessment - EU Manufacturing Site

Based on the “Technical Cooperation Programme (TCPIII)”, medical device manufacturers located in the European Union, Switzerland, and Liechtenstein may apply for a QSD conformity assessment through an abbreviated application mode.

These manufacturers can submit inspection reports issued by designated Notified Bodies (official letter; Traditional Chinese only), along with relevant supporting documents, to be exempt from submitting certain quality documentation during the assessment process.

Know More About the Designated Notified Bodies in EU

No	Country	Name, Notified Body Number, and Address of EU Medical Device Notified Bodies
1	Netherlands	DEKRA Certification B.V. Notified Body 0344 Meander 1051, 6825 MJ Arnhem, The Netherlands
2	France	GMED Notified Body 0459 1, rue Gaston Boissier, 75015 PARIS, France
3	Germany	mdc medical device certification GmbH Notified Body 0483 Kriegerstraße 6, 70191 Stuttgart, Germany
4	Germany	DNV MEDCERT GmbH Notified Body 0482 Pilatuspool 2, 20355 Hamburg, Germany
5	Germany	TÜV Rheinland LGA Products GmbH (TRLP) Notified Body 0197 Tillystr. 2, 90431 Nuremberg, Germany
6	Germany	TÜV SÜD Product Service GmbH Notified Body 0123 Ridlerstraße 65, 80339 Munich, Germany
7	Netherlands	BSI Group The Netherlands B.V. Notified Body 2797 Say Building, John M. Keynesplein 9, Amsterdam, The Netherlands
8	Germany	DQS Medizinprodukte GmbH Notified Body 0297 August-Schanz-Straße 21, 60433 Frankfurt am Main, Germany
9	Germany	DEKRA Certification GmbH Notified Body 0124 Handwerkstraße 15, 70565 Stuttgart, Germany
10	Norway	DNV PRODUCT ASSURANCE AS Notified Body 2460 Veritasveien 1, N-1363 Høvik, Norway

Specific Documents Required:

Certificate of Free Sale (CFS) or Free Sale Certificate (FSC)
ISO 13485 Certificate
Audit Report

Certificate of Free Sale (CFS) or Free Sale Certificate (FSC)

Must be an original copy
Must be issued within the past two years
A reference table should be prepared if multiple items are involved

Must clearly specify the actual manufacturing site, including the name and address

Common Requirements for CFG, CFS, or FSC Used in US and EU Abbreviated Applications or QSD Essential Mode Applications:

Must be an original copy. Authentication is not required.
Must be issued within the last two years.
Must clearly state the actual manufacturing site under “manufacturer” or “production site”. The name and address must match the information submitted in the QSD application.
All product items included in the QSD application must be covered and supported by the CFG, CFS, or FSC. If multiple items are included, or if the product names are not clearly identifiable in the certificate, it is recommended to provide a comparison table to clarify the correlation.

Audit Report (MDSAP)

Must be issued by the same Notified Body, listed above, that issued the ISO 13485 Certificate

The manufacture inspection date stated in the audit report must be within one year prior to the application submission date

The manufacturer’s name and address must match those stated in the application form

If any non-conformities are reported, corresponding CAPA must be submitted.

For new registration and subsequent extension applications, the audit report must include at least one of the newly registered or additionally added items

For BSI audit reports, Z1 Form Visit Receipt or Audit Receipt signed by the auditor must be attached