Europe’s First Medically Certified
Liquid Inhalation Device

The EU MDR 2017/745 is the European Union’s updated medical‑device regulation, replacing older directives to ensure higher standards of safety, performance, and traceability across a device’s entire lifecycle. It classifies products by risk (Class I–III) and requires medium‑ and high‑risk devices (including Class IIa inhalers like Curaleaf’s Medical Grade Inhaler) to undergo full technical review, clinical evaluation, and quality‑system audits by an accredited Notified Body before earning the CE mark. Key mandates include robust clinical data, a certified ISO 13485 quality‑management system, unique device identification (UDI) for traceability, and ongoing post‑market surveillance. In short, EU MDR 2017/745 guarantees that Curaleaf’s Medical Grade Inhaler meets the most rigorous European standards for patient safety, consistent performance, and regulatory compliance.

ISO 18562 is the international standard that defines biocompatibility testing for medical‑device breathing‑gas pathways—like those in inhalers, ventilators, and anesthesia machines. It’s split into four parts covering:

1. Part 1: General principles for assessing risk in the device’s gas pathway materials.

2. Part 2: Evaluation of particulate matter released into the airflow.

3. Part 3: Testing for volatile organic compounds and semi‑volatile substances that could off‑gas into the patient’s breath.

By following ISO 18562, manufacturers prove that their inhalation devices release minimal particles or harmful chemicals and are safe for repeated patient use—ensuring every Curaleaf Medical Grade Inhaler meets the highest biocompatibility and safety benchmarks.

ISO 13485 specifies requirements for a quality‑management system (QMS) where an organization must demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements. Key technical elements include:

1. QMS Structure & Documentation

   • Quality Manual & Procedures: Defined processes for design, production, installation, and servicing.

   • Document & Record Control: Version‑controlled documents, secure record retention, change‑history tracking.

2. Risk Management Integration

   • ISO 14971 Alignment: Systematic hazard analysis, risk evaluation and mitigation activities built into each stage of the product lifecycle.

3. Design & Development Controls

   • Design Planning & Inputs/Outputs: Clear design requirements, verification & validation protocols.

   • Design Transfer & Change Control: Procedures to ensure manufacturing documentation accurately reflects approved designs.

4. Supplier & Purchasing Controls

   • Supplier Qualification: Risk‑based evaluation of external vendors.

   • Incoming Inspection & Verification: Defined acceptance criteria for purchased components and services.

5. Production & Process Validation

   • Process Validation: IQ/OQ/PQ for critical processes (e.g., sterilization, assembly, packaging).

   • Work Instructions & Traceability: Device history records linking serial numbers to production batches, materials, and test results.

6. Corrective & Preventive Action (CAPA)

   • Nonconformance Handling: Defined workflows for deviation investigations, root‑cause analysis, and implemented corrective actions.

   • Trend Analysis: Statistical monitoring to identify systemic issues and drive continuous improvement.

7. Complaint Handling & Vigilance

   • Feedback Loop: Procedures for logging, evaluating, and addressing customer complaints and adverse‑event reports.

   • Regulatory Reporting: Timely notification to Notified Bodies or Competent Authorities as required.

8. Internal Audits & Management Review

   • Audit Program: Scheduled, risk‑based audits of all QMS processes.

   • Management Review: Periodic top‑management review of QMS performance, resource needs, and improvement opportunities.

9. Regulatory Liaison

   • Technical File/Design Dossier Maintenance: Up‑to‑date documentation to support CE‑mark (EU MDR), FDA 510(k), or other global submissions.

   • Labeling & UDI Requirements: Ensuring device identification and labeling meet regional regulations.

Compliance to ISO 13485:2016 not only supports CE‑marking under EU MDR but also provides a globally recognized QMS framework that dovetails with FDA QSR (21 CFR 820) and other national requirements.

Good Manufacturing Practice (GMP) certification ensures that a production facility consistently manufactures products to defined quality standards and regulatory requirements. Key technical elements include:

1. Facility & Equipment Controls

   • Layout & Workflow: Defined zones (raw‑material, in‑process, finished‑goods) with unidirectional flow to minimize cross‑contamination.

   • Environmental Monitoring: Controlled temperature, humidity, particulate counts, and microbial limits per ISO 14644 (for cleanrooms).

   • Equipment Qualification: IQ/OQ/PQ protocols for all critical machinery (mixers, filling lines, sterilizers) to verify installation, operational performance, and consistent output.

2. Process Validation & Control

   • Master Batch Records (MBRs): Detailed, step‑by‑step manufacturing instructions, including equipment settings, formula weights, and in‑process checks.

   • Process Validation Studies: Demonstration that critical steps (e.g., mixing time, fill volume, sterilization cycle) produce reproducible, within‑specification results.

   • Statistical Process Control (SPC): Real‑time monitoring of key parameters (e.g., torque, pH, fill weight) with control charts and alert thresholds.

3. Personnel & Training

   • Qualification Matrix: Defined training curricula and competency assessments for operators, supervisors, and quality staff.

   • Hygiene & Gowning Procedures: Mandatory gown‑change SOPs, airlocks, and personal‐hygiene practices to prevent product contamination.

4. Quality Management & Documentation

   • Standard Operating Procedures (SOPs): Approved, version‑controlled procedures for every production and QC activity.

   • Deviation & CAPA Systems: Formal process for recording out‑of‑spec events, investigating root causes, and implementing corrective/preventive actions.

   • Batch Release & Quality Review: Final product review by Quality Unit, including review of MBR, QC test results, and environmental logs before sign‑off.

5. Raw‐Material & Supplier Qualification

   • Incoming Inspection: Identity, purity, and microbial testing of raw materials against approved specifications.

   • Approved Supplier List (ASL): Risk‑based audits of key vendors, periodic requalification, and change‑control for material changes.

6. Cleaning & Contamination Control

   • Cleaning Validation: Documented studies demonstrating effective removal of residues and disinfectants between batches.

   • Cross‑Contamination Prevention: Dedicated equipment or validated clean‑out procedures when manufacturing multiple product lines.

7. Regulatory Compliance & Audits

   • Regulatory Inspections: Facility readiness for unannounced inspections by FDA, EMA, MHRA, or other competent authorities.

   • Internal Audits: Routine, risk‑based audits of GMP processes, with documented findings and closure of nonconformances.

GMP certification attests that every aspect—from facility design and equipment qualification to personnel training and documentation—meets the stringent requirements for producing safe, high‑quality medical devices and pharmaceutical products.