Notified Bodies & Certification
Conformity-assessment and certification organizations — auditing quality management systems and issuing the ISO and EU MDR/IVDR certifications that let regulated products reach market.
What this page does not claim
A sector is an organization’s role in the value chain, not a legal category. SPEQ maps the disciplines and standards that role typically operates under; it does not determine which apply to your organization, and a count of decoded standards measures SPEQ’s coverage.
WHAT THIS SECTOR DOES
Notified bodies and certification organizations are the independent third parties that assess whether a manufacturer’s quality system and product conform to the applicable standard — and issue the certificate that lets the product reach market. For medical devices they perform the conformity assessment behind an EU MDR/IVDR CE mark; more broadly they certify management systems against ISO standards. Their independence and competence are the reason a certificate means something.
REGULATORY LANDSCAPE
Device conformity assessment runs on EU MDR (2017/745) and IVDR (2017/746), evaluating the manufacturer’s ISO 13485 quality system, ISO 14971 risk management, and IEC 62304 software lifecycle. Management-system certification bodies operate to ISO/IEC 17021, and the notified bodies themselves are designated and monitored by competent authorities. The certificate is only as credible as the assessor’s accreditation and impartiality.
THE OVERSIGHT MODEL
The relationship is inverted from the rest of the value chain: here the organization is itself the auditor. The manufacturer holds responsibility for its product and quality system; the notified body independently assesses conformity and must remain impartial — it cannot consult on the same system it certifies. Competent authorities, in turn, oversee the notified bodies, so the accountability chain runs manufacturer → notified body → competent authority.
WHAT QUALITY MEANS HERE
Conformity assessment (MDR/IVDR)
Evaluating technical documentation, the QMS, and clinical/performance evidence against EU MDR/IVDR before a CE certificate is issued.
Impartiality & competence
ISO/IEC 17021 independence, freedom from conflict of interest, and demonstrable assessor competence — the basis on which any certificate is trusted.
QMS & risk auditing
Auditing the manufacturer’s ISO 13485 quality system and ISO 14971 risk management, including software lifecycle controls under IEC 62304.
Surveillance & recertification
Ongoing surveillance audits and unannounced inspections that keep a certificate meaningful across its lifecycle, not just at issue.
STANDARDS SPEQ DECODES · 56
Open the full library →WHERE QUALITY FAILS
- Conflicts of interest that undermine the impartiality of the assessment
- Inconsistent or under-scoped audits that let nonconforming product reach market
- Assessor competence gaps for novel technologies or software-driven devices
- Weak post-certification surveillance that misses a QMS drifting out of control
GXP DISCIPLINES IN THIS SECTOR
[ MAJOR CERTIFICATION & NOTIFIED BODIES ]
Accredited certification bodies audit management systems (ISO 9001, 13485, 22000, 42001); those tagged EU Notified Body are additionally designated for medical-device conformity assessment under the MDR/IVDR.
BSI Group
ISO 9001 / 13485 / 42001 certification and one of the largest MDR & IVDR Notified Bodies.
United Kingdom · EU Notified Body · Visit ↗
TÜV SÜD
Medical-device conformity assessment (MDR/IVDR), ISO 13485 and quality-system certification.
Germany · EU Notified Body · Visit ↗
TÜV Rheinland
Product safety, ISO 13485 / 9001 certification and medical-device conformity assessment.
Germany · EU Notified Body · Visit ↗
DEKRA
Medical-device Notified Body services and management-system certification.
Germany · EU Notified Body · Visit ↗
DNV
ISO 9001 / 13485 / 22000 certification, healthcare accreditation and management-system audits.
Norway · EU Notified Body · Visit ↗
SGS
Testing, inspection and certification across ISO 9001 / 13485 / 22000 and GMP audits.
Switzerland · EU Notified Body · Visit ↗
Intertek
Testing, inspection and management-system certification (ISO 9001 / 13485 / 22000).
United Kingdom · EU Notified Body · Visit ↗
UL Solutions
Product safety, medical-device testing and ISO 13485 / 9001 certification.
United States · Visit ↗
NSF
Food safety (ISO 22000, HACCP), dietary-supplement GMP and pharma quality certification.
United States · Visit ↗
DQS
Management-system certification (ISO 9001 / 13485 / 22000 / 42001) and audits.
Germany · EU Notified Body · Visit ↗
Lloyd’s Register (LRQA)
ISO 9001 / 13485 / 22000 certification and assurance / audit services.
United Kingdom · Visit ↗
Bureau Veritas
Testing, inspection and certification across ISO 9001 / 13485 / 22000 and GMP audits.
France · Visit ↗
A curated reference list of accredited bodies. SPEQ does not certify, accredit, or endorse any organization; Notified Body designations and accreditation scopes are held by the bodies themselves.
Notified Bodies & Certification: frequently asked questions
Reference answers on what a notified bodies & certification does, what governs it, and who is accountable for quality.
What is a Notified Body?
A Notified Body is an independent organization designated by an EU competent authority to assess whether a manufacturer’s product and quality system conform to the applicable regulation before the product reaches market. For medical devices it performs the conformity assessment behind a CE mark under the EU MDR (2017/745) or IVDR (2017/746). Its independence and competence are what make a certificate meaningful.
Which standards do notified bodies assess devices against?
Device conformity assessment runs on EU MDR (2017/745) and IVDR (2017/746), evaluating the manufacturer’s ISO 13485 quality system, ISO 14971 risk management, and IEC 62304 software lifecycle. Management-system certification bodies more broadly operate to ISO/IEC 17021.
How is a notified body’s independence maintained?
Notified bodies operate to ISO/IEC 17021 requirements for impartiality: they must be free of conflicts of interest and cannot consult on the same quality system they certify. They are designated and monitored by competent authorities, so the accountability chain runs manufacturer → notified body → competent authority. A certificate is only as credible as the assessor’s accreditation and impartiality.