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.

Medical Guidelines & Recommendations

Clinical guidelines, regulatory resources, and compliance tools

731 resources

All Medical Guidelines & Recommendations 731 American Guidelines 221 European Guidelines 510

731 resources

Cough (acute): antimicrobial prescribing

Clinical Guideline 2019-02-07 European Guidelines Infectious Diseases & Microbiology

Clinical Guideline by NICE in Infectious Diseases & Microbiology (2019).

Medical Guidelines & Recommendations

Cough (acute): antimicrobial prescribing

Community pharmacies: promoting health and wellbeing

Constipation in children and young people: diagnosis and management

Community engagement: improving health and wellbeing and reducing health inequalities

Coexisting severe mental illness and substance misuse: community health and social care services

Colorectal cancer prevention: colonoscopic surveillance in adults with ulcerative colitis, Crohn’s disease or adenomas

Coeliac disease: recognition, assessment and management

Coexisting severe mental illness (psychosis) and substance misuse: assessment and management in healthcare settings

Cirrhosis in over 16s: assessment and management

Clostridioides difficile infection: antimicrobial prescribing

Chronic pain (primary and secondary) in over 16s: assessment of all chronic pain and management of chronic primary pain

Children’s attachment: attachment in children and young people who are adopted from care

Chronic obstructive pulmonary disease (acute exacerbation): antimicrobial prescribing

Child abuse and neglect

Child maltreatment: when to suspect maltreatment in under 18s

Challenging behaviour and learning disabilities: prevention and interventions

Cellulitis and erysipelas: antimicrobial prescribing

Cerebral palsy in adults

Care of dying adults in the last days of life

Cataracts in adults: management

Care and support of people growing older with learning disabilities

Cannabis-based medicinal products

Cardiovascular disease: risk assessment and reduction, including lipid modification

Bronchiolitis in children: diagnosis and management

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