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.
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.
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.
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.
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.
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.
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.
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.
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.
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