Is Combination Product regulation available for Europe?

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I What are examples of a Combination Product (Medical device and Pharmaceutical) ? ISO 13485:2016 - Medical Device Quality Management Systems 14
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A Establishment Registration Requirements - Combination Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
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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M FDA News USFDA draft guidance – Principles of Premarket Pathways for Combination Products; Draft Guidance for Industry; Availability Medical Device and FDA Regulations and Standards News 0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
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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
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Q CAPA - Combination of similar issues from different audits ISO 13485:2016 - Medical Device Quality Management Systems 3
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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
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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
I Device Class when used in combination with a device of a higher class? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
O Experience with IMB as Competent Authority of Drug Device Combination Products? EU Medical Device Regulations 5
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J Work Instruction to Calibrate or Verify a Combination Square General Measurement Device and Calibration Topics 15
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Felony Melony New Product Launch - Safe Launch Customer and Company Specific Requirements 1
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I Control Plan (Product/Process specification/ Tolerance) acceptance FMEA and Control Plans 27

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