Is Combination Product regulation available for Europe?

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Michael Malis The FDA proposes to amend the combination product regulation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
M Combination Product - New MAA EU Medical Device Regulations 0
R Compatibility studies - combination product CE Marking (Conformité Européene) / CB Scheme 4
N Is this a single integral drug device combination product EU MDR CE Marking (Conformité Européene) / CB Scheme 1
M Differences in post market safety reporting for Combination Product Applicants Medical Device and FDA Regulations and Standards News 1
S Definition of Convenience Kit for a Combination Product US Food and Drug Administration (FDA) 0
V Submission for a cross-labelled combination product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
V For a Drug-Device Combination Product, 'Design Control' Process is triggered at? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
V Design Controls for Combination Drug Product Manufacturer (ANDA) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
F Development Meeting with the FDA - Approval Pathway for a Combination Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
B Combination Product South Africa CTD Other Medical Device Regulations World-Wide 1
S Any advice for my Pre Approval Inspection (PAI) for Combination product ? US Food and Drug Administration (FDA) 1
S Contract Manufacturer - Product Identification for Combination medical device Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 8
N Japan Combination Medical Device Product Regulations and Requirements Japan Medical Device Regulations 2
I What are examples of a Combination Product (Medical device and Pharmaceutical) ? ISO 13485:2016 - Medical Device Quality Management Systems 14
W FDA Preapproval Inspection - Submitting a 505b2 for a combination product to the FDA Other US Medical Device Regulations 5
A Establishment Registration Requirements - Combination Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
F What Combination (Combined Advanced Therapy Product) Products are Approved in the EU? EU Medical Device Regulations 2
A Combination Product - Legacy Drugs and Reclassification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
bio_subbu US FDA Proposed Rule for Combination Product Reporting US Food and Drug Administration (FDA) 1
M Combination Products MAA in Europe Medical Device and FDA Regulations and Standards News 3
M Examples of Combination Products - MDR Article 1 (8) and MDR Article 1(9) Medical Device and FDA Regulations and Standards News 3
M Combination products - examples CE Marking (Conformité Européene) / CB Scheme 1
R Compatibility studies for Combination Products - Europe Medical Device and FDA Regulations and Standards News 2
M Europe GMP medical devices - Combination products - Ancillary medicinal substance CE Marking (Conformité Européene) / CB Scheme 4
C Combination Products - Distributor of the device? EU Medical Device Regulations 7
B Accessible parts per 8.4.2 b) - Touch currents in combination with MOOP or MOPP? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Informational US FDA Final guidance – Postmarketing Safety Reporting for Combination Products Medical Device and FDA Regulations and Standards News 0
M Informational EMA – Consultation on draft guideline on quality requirements for medical devices in combination products Medical Device and FDA Regulations and Standards News 0
K Release testing for Combination Drug-Medical Device Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
A UDI requirements for pre-filled combination devices - Box containing a pre-filled device US Food and Drug Administration (FDA) 2
M FDA News USFDA draft guidance – Principles of Premarket Pathways for Combination Products; Draft Guidance for Industry; Availability Medical Device and FDA Regulations and Standards News 0
I Label Expiration Date - Single Use Combination Medical Device EU Medical Device Regulations 2
B Will FDA Inspect a New Coating Supplier for a Class III Combination Medical Device? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Shelf Life of Combination Sets for Class II Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 4
V Upgrading Systems from CFR 211 to CFR 820 (drug+device combination) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
B Article 12 Combination Device Registration With Competent Authority CE Marking (Conformité Européene) / CB Scheme 4
B Design history files for combination products 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
V Combination of software used as a single medical device ISO 13485:2016 - Medical Device Quality Management Systems 1
AnaMariaVR2 The Essential Guide to Combination Products cGMPs Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
Q CAPA - Combination of similar issues from different audits ISO 13485:2016 - Medical Device Quality Management Systems 3
B Best format for a combination ISO 9001/ISO 13485 Quality Manual? Quality Management System (QMS) Manuals 6
Q Books that have a combination of ISO 13485 and FDA Title 21 CFR Part 820 ISO 13485:2016 - Medical Device Quality Management Systems 9
E Harms Severity Scoring - Combination of Hazards ISO 14971 - Medical Device Risk Management 4
J ISO 22000, PAS 220 and HACCP Combination. Food Safety - ISO 22000, HACCP (21 CFR 120) 10
R Combination of Text and Flowchart based Procedures Document Control Systems, Procedures, Forms and Templates 18
I Analyte Specific Reagents (FDA requirements) for combination Antibodies US Food and Drug Administration (FDA) 7
F DIA (Drug Information Association) Conference on Combination Products EU Medical Device Regulations 1
P Standard for Microbial Limits for a Combination Device - Impregnated Retraction Cord EU Medical Device Regulations 1
B Format of Device Master Record (DMR) for Combination Products 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1

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