Innovative Regulatory Affairs Strategies for Innovative Products
EU/UK Legal Representative Services
- IDEA is passionate about getting innovative products to patients with unmet needs and we particularly enjoy putting our full weight of innovative thinking and regulatory expertise behind innovative medicine.
Helping you to help
- Our goal is to attain the best possible results for patients, by understanding the goals of our clients, cooperating with authorities, and utilising available regulatory incentives to accelerate assessment, while delivering quality data for regulatory approval.
Working as part of
- We work as part of your team and are fully with you on your regulatory journey , helping to navigate the complex and ever-evolving global regulatory and market access environments, pre-empting and managing the common misunderstandings that can cause you unexpected costs and delays.
Pharmaceutical industry knowledge
The medical devices and in vitro diagnostics world has changed significantly under much tighter regulations. One standout example is the Medical Devices Regulation (MDR), which was adopted by the European Parliament and the Council in 2017. The Regulation states that medical devices can be placed on the EU market under CE certifications issued until 26 […]
When the Medical Devices Regulation (MDR) came into force, many notified bodies decided not to pursue accreditation. Others are still waiting to get approval. That has meant far fewer notified bodies to perform assessments and more experienced medical device reviewers retiring or moving to industry. The challenge for notified bodies is compounded by the fact […]
The Medical Devices Regulation has created some turmoil for manufacturers, particularly smaller companies, as they try to navigate a host of new requirements. Devices that previously would not have had to undergo conformity assessments with the notified bodies may now be classed differently and require assessment. That adds an extra layer of cost and complexity, […]