Marie Gallagher at Medical Technology Conference
On 21st October, 2021 our Regulatory Affairs/Quality Consultant, Marie Gallagher presented an overview of the importance of a regulatory strategy in the MDR/IVDR world. This session was one of the key ‘must listen to’ topics especially because IVD regulations are right around the corner. Many companies are facing a tough time to transition their innovation and comply with IVDR.
Marie started with giving a brief introduction to Regulatory Strategy helping the audience to understand why a regulatory strategy was an important step whilst innovating a medical product.
A regulatory strategy:
- Defines a regulatory pathway for successful commercialisation of your product to your target market
- Encompasses key milestones and decision points
- Considers regulatory objectives, landscape, and characterises risk
- Acts as a roadmap to Innovators to market their product in other target regions
- Ultimate goal is to enable patient access
Additionally, a regulatory strategy can serve as the basis of the marketing + financial planning process. Our experts have helped 68 companies with a robust regulatory strategy and today, these innovations are successful products complying with MDR/IVDR requirements.
Innovators need to understand the aspects of a regulatory strategy and Marie clearly highlighted these during her presentation as she mentioned that a regulatory strategy:
- Comprises three essential elements:
- Device qualification & classification
- Compliance requirements
- Compliance ownership
- Estimation of cost, timeline and complexities of approval activities are dependent on regulatory requirements
- Considerations and requirements differ depending on target market
As an innovator, the above points should emphasise to you the importance of a Regulatory Strategy and so, by now, you should have your mobile phone in hand and sending an email to firstname.lastname@example.org to receive expert advice for your medical innovation.
If not …
Here are some more facts highlighting the importance of a regulatory strategy:
- MDR (2017/745) and IVDR (2017/746) - stricter requirements, broader scope and increased responsibilities
- Access to regional markets is always preceded by regulatory approvals
- Avoids regulatory mishaps, potential business risk and delays to innovation
- Highlights the work that is required – what/where/when/why/who?
- Competitive advantage
- Impressive to potential Investors
- Risk mitigation
Our experts have 25+ years of expertise in the MedTech sector. Feel free to send us an email to email@example.com for one FREE consultation. This consultation can get your medical device compliance activities up and running.