EU MDR Notified Body Submission Toolkit
Complete EU MDR notified body application package templates — NB application checklist, technical file index, GSPR compliance matrix, SSCP, deficiency response tracker, and EU Declaration of Conformity.
What You Get
NB Application Package Checklist (EU MDR Annex IX + X + XI)
Complete checklist for assembling a notified body conformity assessment application package. Covers manufacturer qualification documents, QMS certification evidence, technical documentation index, clinical evaluation summary, and the NB-specific application forms. Maps each required element to the applicable EU MDR Annex and identifies the most common deficiency queries by NB type.
Technical File Index and Document Control Template
Master index template for EU MDR technical documentation files. Structured for Annex II Part A (technical description) and Part B (clinical evaluation). Includes document version control, review status tracking, and the document map that notified body reviewers use to navigate your technical file during conformity assessment.
General Safety and Performance Requirements (GSPR) Checklist (Annex I)
Complete GSPR checklist covering all 23 general requirements in EU MDR Annex I. For each requirement: applicability determination, compliance demonstration method, supporting documentation reference, and residual risk acceptability statement. Structured as the compliance matrix notified bodies review at the start of every technical file audit.
Summary of Safety and Clinical Performance (SSCP) Template (Article 32)
SSCP template pre-formatted for EUDAMED upload and notified body review. Covers device description, indications and intended purpose, clinical evidence summary, residual risks and undesirable effects, patient population information, and manufacturer information. Structured per MDCG 2019-9 guidance with guidance notes for each required section.
NB Deficiency Response Tracking Template
Structured tracking system for managing notified body queries and deficiency responses during conformity assessment. Covers query categorization (minor vs major), response due date tracking, evidence package assembly, resubmission version control, and the communication log that supports escalation if NB review stalls. Pre-formatted for the typical 3-round NB review cycle.
EU Declaration of Conformity Template (Article 19)
EU Declaration of Conformity template meeting all Article 19 and Annex IV requirements. Covers manufacturer identification, device identification, conformity assessment route, harmonized standards applied, notified body identification, authorized representative details, and the authorized signatory requirements. Pre-formatted for both initial CE marking and post-market surveillance updates.
FAQ
How long does EU MDR notified body conformity assessment take?
Typically 12-24 months for Class IIb and III devices from initial application to CE certificate issuance. Class IIa devices under Annex IX typically run 6-12 months. Deficiency response cycles are the primary source of delay.
What is the GSPR checklist and is it required?
The GSPR checklist (or compliance matrix) documents how your device meets each of the 23 general safety and performance requirements in EU MDR Annex I. It is not explicitly mandated by EU MDR but is universally requested by notified bodies as part of technical file review.
What format are the documents?
All documents are editable Word and Excel templates ready for direct use in your EU MDR technical documentation file.
Ready to get started?
For informational purposes only. Not legal or regulatory advice. Legal