Sampling the buffet of scientific advice with rare disease product development

Sponsors of products for rare diseases must manage a complex environment and often in a much shorter timeframe to meet high unmet need. However, they have one significant advantage: access to free scientific advice from the European Medicines Agency (EMA). Orphan Drug Designation, the PRIME (PRIority MEdicines) scheme, conditional marketing approval – these and other […]

Liability or life-saving: The risks associated with IVDs in personalised medicine

Over the past 10 to 15 years, there has been a steady trend towards personalised medicine, particularly in the field of oncology. This has led to increased use of in vitro diagnostic products, or investigational IVDs, to determine the right medicine for the patient. It is worth noting that personalised medicine is not a new […]

It’s a new, more costly world for medical devices – preparation is key!

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 […]

More work, fewer resources and broad uncertainty put pressure on notified bodies

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 […]

Why navigating the MDR is creating uncertainty for many smaller manufacturers

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, […]

European Parliament’s approval of MDR delay brings relief but questions remain

The European Parliament’s approval of the proposal to delay the Medical Device Regulation transition period brings some reassurance to the industry. In February 2023, the Parliament voted by an overwhelming majority to adopt the European Commission’s proposal to delay the transition. The delay extends the deadline for higher risk class III and class IIb devices […]

The reasons, risks and benefits of changing your legal representative

Under both the Clinical Trials Directive and Clinical Trial Regulation, changing your legal representative is considered as serious as a change of sponsor, and involves a substantial amendment. The reason for this is that the liabilities of both the legal representative and the sponsor are tied to one another. For companies that have selected a […]

Start with the end in mind: Planning your clinical trial strategy early on

It has become more important than ever to start thinking and talking about your drug development plan as early as possible. From more complicated protocols and adaptive design to electronic data capture and electronic patient reported outcomes – new technologies are creating opportunities but also adding to the complexity of a clinical trial design. That […]

Asking the Right Questions: Staying Ahead of the CTR and MDR with the EU Legal Representative

The EU legal representative plays a unique role in the life sciences industry and requires a distinctive skill set – with a background in regulatory affairs and quality assurance, but from inside the good clinical practice (GCP) sphere. Now, with the added complexity of the Clinical Trials Regulation and the Medical Devices Regulation, the role […]

IDEA Regulatory Ensures Continuity for Clients Amid Coronavirus

The global coronavirus pandemic, or COVID-19, has brought about both a health crisis as well as personal and business uncertainty. Yet bringing new life saving and life changing products to market remains a pressing priority. Patients are waiting for cures and their needs cannot be postponed. As a leader in providing regulatory affairs expertise and […]