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Medical Device Supply Agreement

Medical Device Supply Agreement Template for Ireland

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Key Requirements PROMPT example:

Medical Device Supply Agreement

"I need a Medical Device Supply Agreement for supplying cardiac monitoring devices to a network of private hospitals in Ireland, with exclusivity rights and including provisions for remote monitoring software updates starting from March 2025."

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Document background
The Medical Device Supply Agreement is a crucial document used when establishing formal supply arrangements for medical devices in Ireland. It serves as the primary contract between medical device manufacturers or suppliers and healthcare providers or facilities, ensuring compliance with both Irish law and EU regulations, particularly the Medical Device Regulation 2017/745 (MDR). This agreement is essential for organizations involved in the supply chain of medical devices, from manufacturers to end-users, and includes comprehensive provisions for quality control, regulatory compliance, risk management, and commercial terms. The document is structured to address the specific requirements of the Irish healthcare system while maintaining alignment with broader EU regulatory frameworks, making it suitable for both domestic and international medical device supply arrangements.
Suggested Sections

1. Parties: Identification of the supplier and purchaser, including registered addresses and company details

2. Background: Context of the agreement, including brief description of the medical devices and purpose of supply

3. Definitions: Detailed definitions of terms used throughout the agreement, including technical and regulatory terms

4. Supply Obligations: Core obligations regarding the supply of medical devices, including ordering process and delivery terms

5. Regulatory Compliance: Obligations regarding MDR compliance, CE marking, and other regulatory requirements

6. Quality Requirements: Quality management system requirements, batch testing, and quality control procedures

7. Price and Payment: Pricing structure, payment terms, and any price adjustment mechanisms

8. Delivery and Acceptance: Delivery terms, inspection procedures, and acceptance criteria

9. Warranties: Product warranties, regulatory compliance warranties, and quality assurance guarantees

10. Liability and Indemnification: Allocation of risks, liability caps, and indemnification obligations

11. Insurance: Required insurance coverage for both parties

12. Term and Termination: Duration of agreement, renewal terms, and termination rights

13. Vigilance and Safety Reporting: Obligations for adverse event reporting and safety monitoring

14. Confidentiality: Protection of confidential information and trade secrets

15. General Provisions: Standard boilerplate clauses including governing law, jurisdiction, and entire agreement

Optional Sections

1. Data Protection: Required if the medical devices process patient data or if parties exchange personal data

2. Training and Support: Include if supplier provides training or technical support for the medical devices

3. Exclusive Supply: Include if there are territorial or customer exclusivity arrangements

4. Minimum Purchase Commitments: Include if purchaser commits to minimum order quantities

5. Storage and Handling Requirements: Required for devices with specific storage or handling needs

6. Import/Export Requirements: Include for cross-border supply arrangements

7. Change Control: Include for devices likely to undergo modifications or upgrades

8. Forecast and Inventory: Include if parties agree to forecasting and inventory management procedures

Suggested Schedules

1. Schedule 1 - Product Specifications: Detailed technical specifications of the medical devices

2. Schedule 2 - Pricing Schedule: Detailed pricing information, including any volume discounts

3. Schedule 3 - Quality Agreement: Detailed quality management requirements and procedures

4. Schedule 4 - Service Levels: Performance metrics and service level requirements

5. Schedule 5 - Regulatory Compliance Checklist: Specific regulatory requirements and compliance procedures

6. Schedule 6 - Order and Delivery Procedures: Detailed procedures for ordering and delivery

7. Appendix A - Contact Details: Key contact persons for various aspects of the agreement

8. Appendix B - Device Documentation: Required documentation including Instructions for Use, labels, and certificates

Authors

Alex Denne

Head of Growth (Open Source Law) @ tiktok³ÉÈË°æ | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

alex.den.21@genieai.co
Relevant legal definitions















































Clauses









































Relevant Industries

Healthcare

Medical Devices

Pharmaceuticals

Biotechnology

Hospital Services

Healthcare Technology

Clinical Research

Medical Equipment Manufacturing

Healthcare Distribution

Relevant Teams

Legal

Procurement

Quality Assurance

Regulatory Affairs

Supply Chain

Operations

Compliance

Risk Management

Medical Affairs

Commercial

Finance

Technical Services

Clinical Engineering

Relevant Roles

Procurement Manager

Medical Device Quality Manager

Regulatory Affairs Director

Healthcare Facility Manager

Supply Chain Manager

Commercial Director

Legal Counsel

Compliance Officer

Medical Device Safety Officer

Operations Manager

Healthcare Contract Manager

Quality Assurance Manager

Chief Medical Officer

Head of Medical Devices

Procurement Officer

Risk Management Officer

Industries










Teams

Employer, Employee, Start Date, Job Title, Department, Location, Probationary Period, Notice Period, Salary, Overtime, Vacation Pay, Statutory Holidays, Benefits, Bonus, Expenses, Working Hours, Rest Breaks,  Leaves of Absence, Confidentiality, Intellectual Property, Non-Solicitation, Non-Competition, Code of Conduct, Termination,  Severance Pay, Governing Law, Entire Agreemen

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