QMS & Global Regulatory ServicesSelecting the appropriate conformity assessment body is a critical step in establishing regulatory compliance for medical devices. The selection process can be complex and technically demanding, as it requires a detailed understanding of the device's intended purpose, risk classification, applicable regulatory framework, conformity assessment route, and the technical competence and designated scope of the assessment body.
EU Notified Body Identification and Selection
We assist medical device manufacturers in identifying and evaluating suitable EU Notified Bodies for conformity assessment under the Medical Device Regulation (EU) 2017/745 (MDR) and, where applicable, the In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR).
Our support includes:
- NANDO Database Assessment: The official database to identify Notified Bodies designated under the applicable MDR or IVDR.
- Regulatory Code Mapping: Evaluating the relevant device designation codes, including MDA, MDN, MDS and, where applicable, MDT codes under MDR, or the relevant IVR and other applicable codes under IVDR. This helps identify Notified Bodies with the appropriate technical competencies for the device.
- Device-Specific Scope Evaluation: Assessing the device's intended purpose, classification, technology, materials, manufacturing processes, and special characteristics to determine the appropriate requirements.
- Conformity Assessment Route Review: Considering the applicable conformity assessment procedure and whether the Notified Body's designation covers the required assessment activities under the relevant regulation.
- Selection and Application Support: Assisting with the preparation of a shortlist, initial communication, and coordination with potential Notified Bodies regarding application requirements and next steps.
MDSAP Auditing Organization (AO) Selection Support
For manufacturers planning to obtain or maintain certification through the Medical Device Single Audit Program (MDSAP), we also assist in identifying and evaluating suitable MDSAP-recognized Auditing Organizations. List of Authorized Auditing Organization
Our support includes:
- Review of the manufacturer's target markets and the applicable regulatory requirements to be covered by the audit.
- Assistance with initial communication, audit enquiries, and coordination of the selection process.
- We provide structured, evidence-based support to help manufacturers make informed decisions.
