Obtaining a Marketing Authorization (MA) for a medicinal product or a CE marking for a medical device marks a key milestone in the development process. Yet the real demonstration of value often begins after this authorization.
Post-authorization studies (and **PMCF studies – Post-Market Clinical Follow-up – for medical devices, their post-CE marking equivalent) are sometimes perceived as an additional regulatory burden. In reality, they now represent a major strategic lever—scientifically, regulatorily, and economically.
Post-authorization studies and PMCF Studies: What Are the Obligations?
For medicinal products
After a Marketing Authorization granted by the ANSM or by the European Commission following the opinion of the European Medicines Agency, the marketing authorization holder must ensure:
- pharmacovigilance
- the implementation of a Risk Management Plan (RMP)
- the possible conduct of post-authorization studies (PASS, PAES)
In France, the Haute Autorité de Santé may also request post-listing studies, which can condition continued reimbursement and pricing negotiations with the Economic Committee for Health Products.
In other words, the post-authorization studies phase can have a direct impact on price and the long-term sustainability of the product on the market.
For medical devices
For medical devices, Regulation (EU) 2017/745 (MDR) requires post-market clinical follow-up (PMCF).
Manufacturers must demonstrate:
- the ongoing performance of the device
- safety in real-world conditions
- the regular update of the clinical evaluation report
Post-market surveillance (PMS) and vigilance systems are no longer simple administrative obligations; they are now part of a broader logic of continuous evidence generation.
Source:
MDCG Guidance on PMCF
A Regulatory Constraint… That Structures Evidence Generation
For both medicines and medical devices, post-authorization studies pursue several objectives:
- detecting rare safety signals
- documenting under-represented patient populations
- confirming the benefit–risk balance in real-world settings
Regulators now expect robust, transparent, and exploitable data.
The European regulatory framework follows the same logic as Regulation (EU) 536/2014 on clinical trials and MDR 2017/745 for medical devices: less bureaucracy, but greater scientific requirements.
Source:
EMA programme on real-world data
…But Above All a Strategic Lever
Generating Real-World Evidence (RWE)
Clinical trials demonstrate efficacy in controlled conditions.
Post-authorization studies
or PMCF studies demonstrate:
- effectiveness in routine clinical practice
- adherence and real-world use
- organizational impact within healthcare systems
In a context where payers and healthcare institutions increasingly demand evidence of efficiency, real-world data becomes a key differentiating factor.
Securing Reimbursement and Pricing
For medicines, post-authorization data can:
- strengthen SMR (Medical Benefit) and ASMR (Added Medical Benefit) assessments
- support price renegotiations
- prevent a downgrade in reimbursement level
For medical devices, health-economic studies may facilitate:
- inclusion on reimbursement lists
- price justification
- integration into healthcare pathways
The post-commercialization phase therefore becomes a major market access tool.
Strengthening Scientific Credibility
Publications, registries, and academic collaborations play an essential role.
Post-authorization studies contribute to establishing a product’s long-term presence in clinical guidelines and routine medical practice.
In several therapeutic areas—such as oncology, rare diseases, and implantable medical devices—this strategy has become indispensable.
Toward a Model of Continuous Evidence Generation
The traditional distinction between “development” and “post-marketing” phases is gradually disappearing.
Health databases, patient registries, connected devices, and predictive analytics are pushing industry toward a continuous evidence generation model.
Post-authorization studies are no longer the end of the regulatory process.
They are the strategic extension of clinical development.
Conclusion: Obligation or Opportunity?
For both medicinal products and medical devices, post-authorization studies are a strong regulatory requirement.
However, companies that integrate them early in the development phase—anticipating the expectations of regulators and payers—transform this constraint into a competitive advantage.
The real question is no longer:
“Should we conduct post-authorization studies?”
but rather:
“How can post-authorization studies be used to sustainably strengthen the clinical and economic value of our products?”
