The path is long. We make it legible.
EU regulation for medical devices and diagnostics is dense, layered, and unforgiving. The journey through it has a clear shape — once someone shows it to you.
Trying to understand whether your product is a medical device under EU law, and what CE marking would require of you.
You have a draft technical file, quality-management work underway, or a notified-body conversation ahead.
You need a qualified Person Responsible for Regulatory Compliance (PRRC), but aren’t ready to hire one in-house.
Wherever you are, the first step is the same — make the regulatory picture clear enough to act on.
Most founders arrive without answers.
That is the right time to talk to us, not the wrong one. We meet you where you are — whether you arrive with a blank page or a partial quality-management system and a notified-body conversation already underway.
Map your route
We build the regulatory picture together: what kind of product you have under EU law, what it is intended to do, what claims you can make, how it may be classified, and what evidence you will need. You leave with a plan you can actually use.
Plan the work
We define the scope, sequence, timeline, and cost of reaching CE marking. Nothing open-ended — you know what each phase contains before it starts, and who is responsible for what.
Build the foundations
We do the work alongside your team: technical documentation, quality-management foundations, evidence strategy, and notified-body engagement. Existing work is assessed and built on, not thrown out.
Carry it forward
Once you reach CE marking, we can stay on as your external PRRC and senior regulatory partner — carrying the work forward with continuity, judgement, and accountability.
The first phase has standalone value.
If you decide to stop there, you leave with a clear plan and the documentation to support it. For most clients, it is the start of a longer relationship.
Fabola is a senior regulatory practice for medical device developers. We work as a focused team, with a wider network of regulatory, clinical, quality, and laboratory experts we bring in when a file needs them.
That structure is deliberate. A senior team gives you continuity, judgement, and a single point of accountability. The network gives you specialist depth — without the overhead of a large consultancy.
A senior, multidisciplinary practice — by design.
Ingela Mauritzon founded Fabola to bring together the kind of senior, multidisciplinary regulatory work that small medical device developers usually cannot afford to assemble internally.
She has more than a decade of experience across MedTech regulation, clinical diagnostics, and healthcare innovation — including co-founding and running IVD laboratories. Her background spans the UK, Europe, Singapore, and China, with academic work in innovation science alongside regulatory practice.
CE marking is rarely only a documentation exercise. It is a strategic, clinical, technical, commercial, and organisational problem at once — and Fabola works where those meet.
Frequently asked questions.
What is Fabola?
Fabola (Fabola AB) is a Sweden-based senior regulatory consultancy for medical device and IVD developers. We help companies find a clear path through EU regulation to CE marking under the MDR and IVDR — and can stay on afterwards as their external Person Responsible for Regulatory Compliance (PRRC).
What services does Fabola offer?
Regulatory strategy (whether your product is a medical device or IVD, its intended purpose, claims, and classification); planning the scope, sequence, timeline, and cost of reaching CE marking; gap analysis; technical documentation; quality-management foundations; clinical and performance evidence strategy; and notified-body selection, engagement, and audit preparation.
Once a product is on the market, Fabola can act as your external PRRC and senior regulatory partner.
What does it take to bring a medical device or IVD to the EU market?
The route depends on the product’s intended purpose, risk class, and existing evidence. It usually starts with confirming that the product is a medical device or IVD and how it is classified under the MDR or IVDR. From there you identify the gaps in technical documentation and clinical or performance evidence, and close them through verification, validation, evaluation, and documentation work. Products that need a notified body then go through its conformity assessment.
Fabola supports the whole route, from early regulatory strategy through to notified-body audits and the questions that follow.
What is a notified body?
A notified body is an independent organisation designated by an EU member state to carry out specific conformity assessment tasks.
Under the MDR, class IIa, IIb, and III devices, and some class I devices (sterile, measuring, or reusable surgical instruments), need a notified body. Under the IVDR, class B, C, and D devices and sterile class A devices do. The notified body assesses the quality-management system, technical documentation, and supporting evidence against the applicable requirements.
Is “CE certification” the same as CE marking?
Not quite. The CE mark is not a certificate issued by the EU. The manufacturer completes the applicable conformity assessment under the MDR or IVDR and takes responsibility for the product meeting its requirements.
Where a notified body is involved, it issues the relevant certificates once its assessment is complete; the manufacturer then draws up the EU declaration of conformity and affixes the CE mark.
What is a PRRC, and can Fabola act as ours?
Article 15 of the MDR and IVDR requires manufacturers to have at least one Person Responsible for Regulatory Compliance (PRRC) with defined qualifications and experience. Micro and small enterprises do not need that person inside their own organisation, but must have one permanently and continuously at their disposal.
Fabola can fill that role as your external PRRC, so you do not have to hire one in-house before you are ready.
When can Fabola get involved?
At any stage. Many clients come to us at the very beginning, still working out whether their product is a medical device and what CE marking would require. Others arrive mid-journey, with a draft technical file, quality-management work underway, or a notified-body conversation ahead. In both cases we assess what already exists and build on it rather than starting over.
Who founded Fabola?
Fabola was founded by Ingela Mauritzon. She has more than a decade of experience across MedTech regulation, clinical diagnostics, and healthcare innovation, including co-founding and running IVD laboratories. Her background spans the UK, Europe, Singapore, and China.
How do I get in touch?
Email [email protected] to book a call. The first conversation is free, and is a chance to talk through your product, where you are now, and the main regulatory questions ahead of you in the EU.