Navigating IVDR & MDR Regulatory Complexity through Consulting & FSP Solutions

For pharmaceutical firms, these regulatory shifts introduce new hurdles, extended approval timelines, and stricter evidence-generation requirements. Successfully navigating these changes is essential for maintaining market access and operational efficiency. The European Union’s MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746) were implemented to enhance patient safety, product oversight, and post-market surveillance. While these regulations primarily target medical device and diagnostic manufacturers, they also have profound implications for pharmaceutical companies, particularly those involved in: 

• Companion diagnostics (CDx) that guide treatment decisions. 

• Drug-device combination products (e.g., prefilled syringes, autoinjectors, inhalers, and drug-eluting stents). 

• Collaborations with medical device or diagnostic manufacturers for co-developments. 

Staying ahead of regulatory changes is crucial for pharmaceutical companies, yet the complexity and evolving nature of regulations such as IVDR and MDR present significant challenges. A specialist outsourced resourcing provider can often provide the optimal solution for ensuring comprehensive and cost-effective support, whether you need individual experts or fully dedicated teams for one product or an entire project or program. 

What IVDR/MDR Means for Pharma: Three Key Areas to Watch 

Failing to fully understand or comply with IVDR and MDR requirements can have significant consequences. For example, a pharma company who do not take these regulations into consideration when planning their trials, neglect or misinterpret an aspect of requirements may discover at the end of the process that they must restart a clinical trial or resubmit portions of their data. Delays escalate costs and hinder progress, impacting timelines, budget and overall success. 

Regulatory and clinical teams must now possess in-depth knowledge of device regulations, combination products, and CDx requirements. Meeting the stringent standards of IVDR and MDR requires more than a cursory understanding, it needs direct involvement in the regulatory process. This necessitates cross-functional planning, proactive communication, and access to expert resources to prevent critical details from being overlooked. 

Below are three key areas where IVDR/MDR directly impact pharmaceutical companies. 

1. Stricter Requirements for Companion Diagnostics (CDx) 

What’s Changing? 

Under the IVDR (Regulation (EU) 2017/746), companion diagnostics previously self-certified under the IVD Directive are now classified as high-risk Class C devices, meaning: 

• Notified body involvement is mandatory for CDx approvals. 

• The European Medicines Agency (EMA) now plays a role in assessing CDx during drug approvals. 

• Additional clinical evidence may be required, even for previously approved diagnostics. 

Why It Matters for Pharma 

Pharma companies developing targeted therapies rely on CDx to stratify patient populations and guide treatment decisions. With IVDR: 

• CDx approval must align with drug approval, which means regulatory timelines for both must be carefully managed. 

• Notified bodies now assess CDx clinical evidence separately from EMA’s drug approval process, potentially causing delays. 

• The limited number of IVDR-designated notified bodies could create a bottleneck for CDx approvals. 

Key Takeaway

Pharma companies must ensure their diagnostic partners have a clear IVDR strategy and plan regulatory submissions in parallel with drug approvals to avoid market delays. 

Expertise Needed

Specialist regulatory professionals with IVDR knowledge and experience in pharmaceutical development are essential to navigating these requirements effectively. 

2. Drug-Device Combination Products: New Compliance Hurdles 

What’s Changing? 

Under MDR (Regulation (EU) 2017/745), drug-device combination products (where the drug is the primary mode of action) now require additional regulatory steps: 

• Pharma companies must obtain a Notified Body Opinion (NBOp) for the device component before applying for EMA approval. 

• Even legacy combination products (e.g., prefilled syringes, inhalers, insulin pens) need to meet MDR requirements when making significant modifications. 

• Clinical evidence requirements are stricter, especially for devices that previously relied on historical data. 

• Why It Matters for Pharma 

• Regulatory complexity increases—MDR and EMA drug approval processes may not always align. 

• Pharma must engage notified bodies earlier, adding time and cost to the regulatory process. 

• The burden of proving device safety and performance now falls more heavily on the pharma company. 

Key Takeaway

Pharma companies should assess whether their drug-device products require new regulatory submissions under MDR and engage with notified bodies early to avoid approval delays. 

Expertise needed

Regulatory specialists with MDR expertise, particularly those with experience in apply MDR to the product development process and notified body interactions, can streamline the approval process and help mitigate potential regulatory obstacles. 

3. The Expanding Role of Notified Bodies and Regulatory Bottlenecks 

What’s Changing? 

One of the most pressing challenges with MDR and IVDR is the limited capacity of notified bodies. Unlike the old directives, where many devices and diagnostics were self-certified, the new regulations require notified body review for: 

• All Class C and D IVDs, including companion diagnostics (IVDR Article 48). 

• All drug-device combination products (MDR Article 117). 

• Yet, the number of designated notified bodies remains critically low. For example: 

• As of 2024, only 13 notified bodies are designated under IVDR (compared to over 20 under the previous IVD Directive). 

• Many notified bodies have long review timelines, making it difficult for pharma companies to align device and drug approvals. 

Why It Matters for Pharma 

• Potential market delays: Without timely notified body assessments, drug launches could be postponed if the diagnostic or device component is not approved. 

• Strain on regulatory resources: Pharma companies working with device or diagnostic partners must account for additional regulatory interactions. 

• Increased compliance costs: Notified body fees and consulting expenses are rising due to high demand. 

Key Takeaway 

Early engagement with notified bodies and careful regulatory planning are essential for pharma companies to avoid bottlenecks in their approval timelines. 

Expertise Needed

Regulatory experts with a deep understanding of notified body processes and a proven track record in pharmaceutical compliance are invaluable in navigating these regulatory complexities. 

Conclusion 

While IVDR and MDR primarily target the medical device and diagnostic industries, their impact on pharma is profound, particularly for companies developing companion diagnostics, combination products, or integrated medical technologies. 

What Pharma Companies Should Do Now: 

• Assess whether current drug-device products and CDx need updated regulatory submissions. 

• Align regulatory timelines with notified body capacity to prevent approval delays. 

• Strengthen partnerships with device and diagnostic manufacturers to ensure compliance with IVDR/MDR. 

Navigating these regulations requires a strategic approach to regulatory planning and engagement with notified bodies. Pharma companies must go beyond traditional vendor relationships and instead seek true strategic partners with deep expertise in IVDR, MDR, and pharmaceutical regulatory pathways. Having access to specialists in this field, leveraging on their experience in product development and regulatory approvals knowledge of IVDs and MDs, is critical.  

With an agile approach free from the administrative burdens of larger suppliers, Eliassen ensures that companies receive the right expertise at the right time without unnecessary delays or bureaucracy. Partner with us to keep your development on track, on budget, and fully compliant with evolving EU regulations.