Expansion Opportunity for DiGA Manufacturers

PECAN
Consulting

DiGA manufacturers have a major opportunity: With PECAN, France has introduced its equivalent to the German DiGA Fast-Track Process. Together with our French partners, we support you to bring your DiGA to France.

PECAN in a Nutshell PECAN Bootcamp

PECAN in a Nutshell

What Is PECAN?

PECAN
is the French equivalent to the German DiGA Fast-Track process

While PECAN is similar to DiGA, there are major
differences.

For DiGA manufacturers, PECAN is an opportunity to expand their business.

With our French PECAN partners and extensive DiGA expertise, we bring your DiGA to the French market.

Why Should You Care?

Fast Access
to the French Market

Fast Preliminary Listing
and Reimbursement

Utilize Existing DiGA Studies
for PECAN Listing

Leverage Your Existing DiGA in a New Market

PECAN Bootcamp

Bring your existing DiGA to France, or consider the PECAN requirements already in your current DiGA development.

Everything your team needs to know about PECAN, the French DiGA equivalent, in one interactive virtual bootcamp.

PECAN Basics and Market
Product Requirements for PECAN
Technology Requirements for PECAN
Evidence Requirements for PECAN
PECAN Listing Process

Get Up-To-Speed with PECAN

PECAN in a Nutshell

French DiGA-Equivalent

PECAN is short for Prise en Charge Anticipée Numerique des Dispositifs Médicaux, and can best be translated as: “Early Access to Reimbursement for Digital Medical Devices“. Fundamentally – with some differences – it is the French equivalent to the German DiGA fast-track process to qualify digital medical devices for reimbursement in France.

Telemedicine Support

In contrast to the German DiGA process, not only therapeutic applications can be eligible for PECAN, but also applications for telemonitoring use cases. While similar changes to the DiGA guidelines are expected for the future, PECAN’s inclusion of telemedical applications opens it up for a vast amount of applications that are not eligible for DIGA approval as of now.

Specific Requirements

The PECAN program also comes with specific requirements that are evaluated in the PECAN process:

Innovative in nature, specifically with regards to its impact on the organization of care and/or its clinical benefits
CE certified and compatible with French standards for interoperability and security in digital healthcare (interoperability certificate mandatory for permanent reimbursement, not yet for preliminary listing under PECAN)
The application is not yet reimbursed in France

Application Material

For the application, three different documents have to be submitted:

A dossier for interoperability and security assessment
A dossier of medical and technical specifications
A dossier with economic information

DiGA vs. PECAN

	DIGA (Germany)	PECAN (France)
Eligible Solutions	Digital Therapeutic Devices	Digital Therapeutic Devices Remote Monitoring Devices
Risk Classes	Class I Class IIa Class IIb expected end of 2023	Class I Class IIa Class IIb Class III
Preliminary Listing	12 Months Optional (and Common) 12 Months Extension	12 Months (Non-Renewable)
Evidence Requirements	Medical Benefits or Patient-Relevant Improvement of Structures or Processes	Clinical Benefits and/or Progress in the Organization of Care
Technical Requirements	Further-Reaching Security, Privacy, Interoperability, and Accessibility Standards	Interoperability and Security Standards by Agence du Numérique en Santé (evaluated during PECAN process, no certificate needed in the beginning)
Authority	Innovation Office at BfArM	CNEDiMTS at HAS French Ministry of Health ANS

Get PECAN-Listed

Talk to Our Experts

Market Access Experts

We know what matters, when it comes to Digital Health Applications.

We are trusted and experienced partners for Digital Health Applications: With the experience from more than 20 DiGA projects, we advise our clients from the very first strategy, regulatory requirements, and listing, to the commercialization of their digital health applications and beyond.

Local PECAN Partner

We work with French PECAN-experts to get your health application PECAN-listed.

For your successful PECAN-listing, we work with our experienced and trusted French partners from MD101, who are renowned experts for market access to the French market and PECAN.