For the European market, when a device is placed on the market forming a single integral product together with a medicinal product and it is not reusable, it shall be governed by the Medicinal Products Directive 2001/83/EC (MPD) applying the requirements of Annex I to the Medical Devices Directive 93/42/EEC (MDD), as far as safety and performance-related device features are concerned.

General The objective of this SOP is to specify and describe the all necessary system prerequisites for developing and marketing a combination product following 21 CFR Part 4. Regulatory basis, reference documents

• AAMI/ANSI HE74 Human factors design process for medical devices
• AAMI/ANSI HE75 Human factors engineering – Design of medical devices
• IEC 62366Medical Devices – Application of human factors engineering to medical devices
• ISO 14971: Medical Devices – Application of risk management to medical devices
• ISO 9241Ergonomics of human-system interaction – Part 210: Human-centred design for interactive systems
• Food and Drug Administration, CDRH: Do it by design: An introduction to Human Factors in Medical Devices
• Food and Drug Administration, CDRH: Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management
• ANSI/AAMI/ISO 13485 Medical Devices – Quality Management Systems
• Food and Drug Administration, CDRH: Write it right: Recommendations for developing user instruction manuals for medical devices used in home health care
• 21 CFR Part 820: Quality System Regulation
• 21 CFR Part 4 Current Good Manufacturing Practice Requirements for Combination Products
• 21 CFR Part 3 Product Jurisdiction

Table of content

1 Purpose and Objective
2 Regulatory basis, reference documents
3 Responsibility and accountability
3.1 Company Management
3.2 Quality Head and Department
4 Related documents
5 Definitions
6 Procedure
6.1 Medical Device and combination Product in US
6.1.1 Medical Device US
6.1.2 Combination Product US
6.2 Medical Devices and combination product in EU
6.2.1 Medical devices EU
6.2.2 Combination Product EU
6.3 Process deliverables
6.3.1 Risk Management
6.3.2 Design Control
6.3.3 Design Change Control
6.3.4 Purchasing Control
6.3.5 CAPA
6.3.6 Non-conformance / Deviation during Development and Production of Combination Products
6.3.7 Post Market surveillance
6.3.8 Post-approval Phase
6.3.9 Training
6.3.10 Market complaints
7 Attachments
8 SOP distribution
9 Health, safety and environmental considerations

Size and Format: Microsoft Office 2003
Word File 13 pages procedure

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