Test your situation in a few minutes: a free online assessment, an instant report, then a lawyer when your case calls for one.
10 questions·5 minutes·Instant report·Your answers stay in your browser
Why now
The upcoming reform lightens the technical burden, but shifts the complexity towards legal interpretation: qualification, derogation regimes, transitional provisions.
These questions are not solved by software or by a technical file. They are solved by legal analysis — at the right time, on the right scope.
Two deadlines are already certain. Certificates issued under the previous regime expire on 31 December 2027 for class III devices and class IIb implantables, and on 31 December 2028 for the other devices concerned. And since 28 May 2026, the first four EUDAMED modules — actor registration, devices and UDI, notified bodies and certificates, market surveillance — have been mandatory. The reform under preparation changes none of these dates.
Product qualification, risk class, conformity route, certification deadlines.
GDPR, certified health-data hosting, how the AI Act interacts with conformity assessment.
Distribution, subcontracting, mandate: how responsibilities are shared between operators.
Non-EU manufacturers: role mapping, choosing an authorised representative, entry strategy.
Your journey
A free online assessment. Ten questions, adapted to your role — manufacturer, distributor or importer. Your email address is required to receive the report.
Enter your e-mail and receive your report: three levels of assessment, the questions your situation raises, your deadlines. A preliminary indication — not legal advice.
If your situation calls for it, a lawyer answers: a one-hour consultation, then a fixed-fee package with a written scope.
Free assessment
Ten questions, three levels of assessment: your market opportunity, your risk and urgency, your need for legal analysis. The path adapts to your role in the supply chain.
Your answers to the questionnaire stay in your browser. Only your email address is sent to us, together with the summary of your report (profile, levels, headings of the points of attention), so that we can provide your report. It is never shared with any third party.
This report is generated automatically from the answers you have entered, without verification and without review of any document. It is provided for information only: it does not constitute legal advice or an opinion, and creates no relationship between you and the firm. It reflects the position at the date it was generated. Some statements rely on proposed Regulation COM(2025)1023, not yet adopted: they reflect anticipation rather than the law as it stands.
Our services
Every package is defined in writing: what it covers, what it excludes, the number of meetings and review rounds. The range shown depends on the scope retained; the firm price is set before any engagement, in an engagement letter. Beyond the agreed scope, nothing is undertaken without your written approval.
€490deducted from any package you take afterwards
One hour with a lawyer to understand your situation and know what to do next.
Call within 10 days. Excludes document review and any written opinion taking a legal position.
€4,500 to €7,5001 product · 3 weeks · 2 meetings
Know what your product legally is, its risk class, its conformity route — with a signed opinion you can put in front of an investor or a notified body.
Excludes drafting the technical file and exchanges with the notified body. Beyond the scope: custom quote.
€6,000 to €9,0001 product · 4 weeks · 2 meetings
Map your health-data processing, secure its legal basis and position your product under the AI Act.
Excludes a full DPIA, technical security audits and handling of an ongoing incident. Beyond: custom quote.
€6,000 to €12,0003 contracts reviewed or 2 drafted · 4 weeks
Bring your contractual chain in line with the MDR and secure the allocation of responsibilities between operators.
One negotiation cycle included; beyond that, time-based billing agreed in writing. Excludes contracts under foreign law.
€2,900 to €4,9002 weeks · 2 video calls
Fast, fixed-price compliance with your own obligations under Articles 13 and 14 of the MDR.
Excludes review of existing supplier contracts (see Medtech contracts) and assistance during an inspection. Beyond: custom quote.
€9,000 to €15,0005 weeks · 3 video calls · deliverables in English
A single legal entry point for a non-European manufacturer seeking access to the Union market.
The firm does not act as authorised representative: that choice guarantees the independence of the advice you receive. Any gaps mentioned with the status obtained from the FDA are set out as a factual comparison of the requirements applicable on each side. They do not constitute an opinion on United States law.
€490 to €990 / monthanswers within 2 business days · no fixed term
A regulatory watch focused on your situation, and a lawyer you can reach for day-to-day questions.
The included time covers questions and orientation; deliverables are quoted as separate packages.
€750 to €2,000 / monthquarterly review depending on plan · no fixed term
Continuous support to keep your deadlines on track and absorb regulatory change as it comes.
The included time covers questions and orientation; deliverables are quoted as separate packages.
A case under control, deadlines met, risks understood: that is what we commit to.
Non-negotiable
The online tool and its report are a preliminary indication. Legal advice begins with the lawyer, under an engagement letter.
Neither CE marking nor an authority's decision can be guaranteed. The firm's commitment covers means, method, scope and deadlines — in writing.
Your answers to the questionnaire stay in your browser. We receive only your email address and the summary of your report — profile, levels, headings of the points of attention — so that we can send you that report and, where relevant, get back to you. Neither is ever sold, rented or shared with third parties, and you may object at any time.
Each package states what is included, what is excluded and what triggers a custom quote. No additional work is undertaken without your written approval.
The firm does not act as authorised representative and receives no referral fees. The advice you get serves your case only.
Before any engagement, the firm checks for conflicts of interest. If one exists, it tells you — and does not open the file.
The firm uses artificial intelligence tools for legal research and to prepare its deliverables. These tools are used under the systematic supervision of a lawyer, who remains solely responsible for the advice given. No document covered by legal professional privilege is processed without appropriate safeguards.
Let's get moving
Start with the free test, or write to us directly: a lawyer of the firm will answer.