The growing demand for GLP-1 receptor agonists (GLP-1 RAs) has highlighted the need for robust regulatory frameworks to ensure the safety, efficacy and quality of drug delivery devices such as pre-filled pens and auto-injectors. For manufacturers targeting multiple markets, navigating the regulatory requirements across regions such as the US, UK and Europe presents significant challenges. Multi-region compliance requires careful alignment of device design, documentation and production practices to satisfy varying standards.
Having a clear understanding of the regulatory frameworks governing GLP-1 injectable devices across major markets is key. This includes the UK’s Medical Device Regulations (UK MDR), the FDA’s requirements in the US, the EU Medical Device Regulation (EU MDR) and global standards established by ISO and ICH. The emphasis here is on manufacturing requirements and standards that ensure compliance in multiple regions.
UK Medical Device Regulations’ (UK MDR’s) requirements for GLP-1 drug delivery devices
The UK Medical Device Regulations (UK MDR), based on the Medical Devices Regulations 2002, outline essential requirements for the safety and performance of medical devices marketed in the UK. These requirements, enforced by the Medicines and Healthcare products Regulatory Agency (MHRA), apply to GLP-1 delivery devices. Let’s take a brief look at the key requirements.
- Safety and performance: Devices must meet general safety and performance requirements, including biocompatibility, sterility, and dose accuracy. Materials used must not compromise patient safety.
- Technical documentation: Manufacturers must maintain thorough technical files detailing design, manufacturing processes, and risk management.
- Clinical evaluation: Evidence of clinical performance and safety must be demonstrated through rigorous testing.
- Post-market surveillance: Manufacturers are required to monitor device performance post-market and report adverse events or non-compliance.
FDA requirements for GLP-1 drug delivery devices
In the US, the Food and Drug Administration (FDA) regulates GLP-1 delivery devices and those parallel as combination products under its guidance for Essential Drug Delivery Outputs (EDDOs). The FDA’s stringent focus on usability and mechanical stress tolerance highlights the need for manufacturers to prioritise robust design and rigorous pre-market testing. Here are some key requirements from this guidance.
- Dose delivery accuracy: Devices must deliver consistent and precise doses, supported by data demonstrating reliability across environmental and mechanical stresses.
- User safety: Design features must minimise user error, ensuring ease of operation and proper functionality.
- Mechanical durability: Devices must withstand physical stresses and maintain integrity during storage and use.
- Regulatory documentation: Manufacturers must provide comprehensive design history files, validation data, and risk management documentation.
EU Medical Device Regulation’s (EU MDR’s) requirements for GLP-1 drug delivery devices
The EU Medical Device Regulation (EU MDR, Regulation 2017/745) sets comprehensive requirements for GLP-1 devices marketed within the European Union. Major considerations include the guidance outlined in MDCG 2021-24, which classifies devices based on risk, duration of use and invasiveness. For GLP-1 devices, manufacturers must adhere to EU MDR’s rigorous risk management protocols and testing standards, which include material compatibility, contamination control and mechanical performance under normal and extreme conditions. Let’s take a closer look at these specific requirements.
- Risk classification: Injectable devices are typically classified as Class IIa or higher. This requires a detailed conformity assessment by an independent organisation accredited under the EU MDR.
- General safety and performance: Annex I outlines stringent requirements for GLP-1 and similar drug delivery devices. This covers factors like biocompatibility, sterility and dosing accuracy.
- Clinical evidence: Manufacturers must demonstrate safety and efficacy through clinical data. This is mandatory for EU MDR compliance.
- Unique device identification (UDI): Labelling must include traceable UDI codes to enhance post-market safety and traceability.
Global standards and their requirements for GLP-1 drug delivery devices
In addition to regional regulations, global standards established by the International Organization for Standardization (ISO) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provide a unified framework for GLP-1 delivery devices. These global standards guide manufacturers in harmonising design and production processes across markets, focusing on compliance whilst maintaining product quality. Some specific specifications and standardisations that relate to GLP-1 drug delivery devices are as follows.
- ISO 11608 series (1 & 6): Specifies requirements for needle-based injection systems, focusing on safety, usability and dose accuracy.
- ISO 11040 series: Addresses specifications for prefilled syringes, ensuring compatibility and performance.
- ISO 11607-1: Governs sterile barrier systems and packaging, ensuring devices maintain sterility until use.
- ICH Q1A (R2): Outlines stability testing requirements, including evaluation of drug-device interactions and environmental stress tolerance.
Successfully navigating multi-region compliance
Achieving multi-region compliance for GLP-1 devices requires planning and integration of regulatory requirements from the initial stages of design all the way to packaging. The following key strategies can help manufacturers streamline compliance when it comes to making these devices to directly improve global market access.
Material and process standardisation
Using globally recognised standards like ISO 11608 for needle-based injection systems ensures compliance with FDA, EU MDR, and UK MDR requirements. Standardising materials and processes across different markets simplifies manufacturing and reduces the risk of non-compliance during regulatory assessments.
Design for Manufacture (DfM)
Aligning device design with compliance requirements early in development helps prevent costly redesigns and regulatory delays. By taking key regulatory requirements into consideration at the early stages of design, manufacturers can ensure that their devices meet safety, usability and performance requirements across multiple markets.
Precision engineering processes
Ensuring high repeatability and compliance with strict regulations requires tight tolerances, advanced forming and pressing techniques and rigorous quality control. By leveraging precision engineering processes like laser deburring and automation, manufacturers can reduce production variability and improve device consistency.
Simplify compliance through optimised manufacturing processes
Navigating the regulatory landscape for GLP-1 injectable devices requires aligning design, manufacturing,and documentation with varying global standards to ensure compliance and market success. Prioritising Design for Manufacture (DfM) and optimised production processes helps in achieving this by enhancing efficiency, reducing waste, and ensuring device reliability across regions. For a more in-depth guide on implementing DfM principles in medical device production, download our guide below
