What is an MDCG guidance document?

MDCG (Medical Device Coordination Group) guidance documents are non-binding technical guidance published by the European Commission to assist manufacturers, Notified Bodies, and competent authorities in implementing EU MDR 2017/745 and EU IVDR 2017/746. They cover clinical evaluation, post-market surveillance, UDI, EUDAMED, and other compliance topics.

What FDA guidance documents are required for a 510(k) submission?

FDA 510(k) submissions must follow applicable FDA guidance documents including the general 510(k) Guidance, device-specific guidances, and quality system regulation (21 CFR Part 820). Key documents include guidance on substantial equivalence determinations, cybersecurity pre-market requirements, and device-type-specific performance standards.

What is a Team NB document?

Team NB (Team of Notified Bodies) publishes position papers, recommendations, and guidance documents developed collaboratively by European Notified Bodies designated under EU MDR and IVDR. These documents clarify application of regulatory requirements and support harmonised conformity assessment practices across Notified Bodies.

What clinical guidelines are available on Medical Device Navigator?

Medical Device Navigator provides access to 700+ clinical guidelines and recommendations from major European and American medical societies including ESC, ESMO, EULAR, AHA/ACC, ASCO, ADA, NICE, and many more. Guidelines are organized by specialty and geographic scope (European vs American) to help medical device professionals understand clinical practice standards relevant to their devices.

Regulatory Resources

Clinical guidelines, MDCG guidance, FDA guidance, standards, and compliance tools

22 resources

Bronchiolitis in children: diagnosis and management

Clinical Guideline 2015-06-01 European Guidelines Medical Guidelines & Recommendations

Clinical Guideline by NICE in Respiratory & Intensive Care (2015).

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Bronchiectasis (non-cystic fibrosis), acute exacerbation: antimicrobial prescribing

Clinical Guideline 2018-12-18 European Guidelines Medical Guidelines & Recommendations

Clinical Guideline by NICE in Respiratory & Intensive Care (2018).

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Brain tumours (primary) and brain metastases in over 16s

Clinical Guideline 2018-07-11 European Guidelines Medical Guidelines & Recommendations

Clinical Guideline by NICE in Neurology & Neurosurgery (2018).

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Borderline personality disorder: recognition and management

Clinical Guideline 2009-01-28 European Guidelines Medical Guidelines & Recommendations

Clinical Guideline by NICE in Neurology & Neurosurgery (2009).

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Blood transfusion

Clinical Guideline 2015-11-18 European Guidelines Medical Guidelines & Recommendations

Clinical Guideline by NICE in Oncology & Haematology (2015).

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Behaviour change: digital and mobile health interventions

Clinical Guideline 2020-10-07 European Guidelines Medical Guidelines & Recommendations

Clinical Guideline by NICE in Public Health & Primary Care (2020).

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Bedwetting in under 19s

Clinical Guideline 2010-10-27 European Guidelines Medical Guidelines & Recommendations

Clinical Guideline by NICE in Paediatrics (2010).

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Barrett’s oesophagus and stage 1 oesophageal adenocarcinoma: monitoring and management

Clinical Guideline 2023-02-08 European Guidelines Gastroenterology & Hepatology

Clinical Guideline by NICE in Gastroenterology & Hepatology (2023).

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Babies, children and young people’s experience of healthcare

Clinical Guideline 2021-08-25 European Guidelines Medical Guidelines & Recommendations

Clinical Guideline by NICE in Paediatrics (2021).

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Brazil ANVISA — RDC No. 751/2022 — Medical Device Registration

Regulation 2022-09-21 Brazil (ANVISA) Regulations

ANVISA RDC 751/2022, effective March 2023, governs medical device registration in Brazil with a risk classification aligned to EU MDR classes I–III. Replaced RDC 185/2001.

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Regulatory Resources

Bronchiolitis in children: diagnosis and management

Bronchiectasis (non-cystic fibrosis), acute exacerbation: antimicrobial prescribing

Brain tumours (primary) and brain metastases in over 16s

Borderline personality disorder: recognition and management

Blood transfusion

Behaviour change: digital and mobile health interventions

Bedwetting in under 19s

Barrett’s oesophagus and stage 1 oesophageal adenocarcinoma: monitoring and management

Babies, children and young people’s experience of healthcare

Brazil ANVISA — RDC No. 751/2022 — Medical Device Registration

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