Hémistiches.Concordance
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ConcordanceMDR and IVDR compliance for medical devices, by Hémistiches

Is your medical device in concordance with the EU Regulation?

Test your situation under Regulation (EU) 2017/745 (MDR) and, for in vitro diagnostics, Regulation (EU) 2017/746 (IVDR). About ten questions on your product, your certificates and your obligations, depending on your role in the supply chain, and an instant report: your points of attention, your deadlines, and the price of what comes next.

Take the test See the services

Five minutesFreeYour answers stay in your browserPrices exclude VAT

The name

In music, concordance is the agreement of voices that sound true together.

For a medical device, it is the agreement between what you place on the market and what the Regulation requires: the qualification of the product, its class, the certificate that covers it, the deadlines that apply to it, and the obligations of each operator in the chain.

The test does not tell you whether your product complies. It identifies where concordance is not established, and what it takes to establish it.

Where does your concordance stand?

Seven to twelve questions, depending on your role and your product. The path adapts: manufacturer established in or outside the Union, distributor or importer, medical device or in vitro diagnostic device.

At the end, you can choose to answer a few questions about your insurance. This section checks whether you have taken the steps needed to have sufficient financial coverage for your liability, as the Regulation requires of manufacturers.

What is at stake now

Medical device compliance is won in the technical file, but also in the texts: qualification, status, transitional regimes, allocation of roles. The test reviews these six points, according to your role.

  • Legacy certificatesThe transition ends on 31 December 2027 for class III and class IIb implantable devices, with exceptions, and on 31 December 2028 for other devices. Subject to conditions.
  • In vitro diagnostics31 December 2027 for class D, 2028 for class C, 2029 for class B and class A sterile. For the last two, an application must be lodged by 26 May 2027 at the latest.
  • EUDAMEDFour modules mandatory since 28 May 2026. Devices already on the market must be registered by the end of November 2026.
  • Qualification and classWhat your product legally is, software included, drives the conformity route, the budget and the timetable.
  • Operators' rolesManufacturer, authorised representative, importer, distributor: each has its own obligations, and a distributor can become a manufacturer without knowing it.
  • The reform under wayThe simplification proposal of 16 December 2025 has not been adopted. Until it is, the current rules and deadlines apply.

Services

Fixed-scope packages, with a written scope. The test tells you where to start; here is the starting point of each service.

Flash consultation

Price

€490 excl. VAT

One hour to go through your report with you, establish your actual situation and decide what to do next.

  • Sixty-minute video call, within ten days
  • Written guidance note
  • Deductible from the package that follows

Qualification and regulatory strategy

From

€3,000 excl. VAT per product

What your product legally is, its class, its conformity route and what your certificates allow.

  • €3,000 excl. VAT for a simple product: clear intended purpose, a single configuration
  • €4,500 to €7,500 excl. VAT for software or AI, a borderline product, a product range or a transition to be checked
  • Signed written document and dated roadmap, in two to three weeks

Distributor or importer compliance

From

€2,900 excl. VAT

Your own obligations, according to your actual role in the chain: verifications, registers, supplier clauses, EUDAMED.

  • €2,900 excl. VAT for a single role, with no work on the product
  • Up to €4,900 excl. VAT for both roles, or a relabelled or repackaged product
  • Two weeks, two video calls

Supply chain contracts

From

€6,000 excl. VAT

Distribution, subcontracting, mandate: contracts that reflect the allocation of obligations set by the Regulation.

  • €6,000 excl. VAT for three existing contracts reviewed
  • Up to €12,000 excl. VAT for two contracts drafted
  • One negotiation round included

EU market access

From

€9,000 excl. VAT

For a manufacturer established outside the Union: the allocation of roles, the choice of authorised representative and review of its mandate, the entry strategy.

  • €9,000 excl. VAT for a simple product
  • Up to €15,000 excl. VAT for a range, software or an in vitro diagnostic
  • Five weeks, deliverables in English

Regulatory watch and follow-up

From

€490 excl. VAT per month

Keeping concordance over time, with lawyer time reserved every month and a watch note on what changes for you.

  • Watch and direct line: two hours a month for €490 excl. VAT, four hours for €990 excl. VAT
  • Deadline follow-up: three hours and a quarterly call for €750 excl. VAT, eight hours and a monthly call for €2,000 excl. VAT
  • No minimum term, one month's notice

What each service includes

  • Flash consultation

    A prior reading of your report and of two or three documents you send, a sixty-minute video call within ten days, and a one-page guidance note: points of attention, priorities, next steps. €490 excl. VAT, deductible from the package that follows. It does not include an in-depth review of documents or a written opinion committing to a legal position.

  • Qualification and regulatory strategy

    A review of your documents (intended purpose claimed, instructions for use, labelling, marketing claims, certificates), the qualification of the product, its class under the rules of Annex VIII to the Regulation, the conformity route and, where relevant, the conditions of the transitional period. A signed written document, which you can show an investor or a notified body: a five-to-eight-page note for a simple product (€3,000 excl. VAT), an eight-to-fifteen-page opinion beyond that (€4,500 to €7,500 excl. VAT), with a dated roadmap and one round of comments. It does not include drafting the technical documentation, the clinical evaluation or exchanges with the notified body.

  • Distributor or importer compliance

    Your actual role in the chain, including under Article 16; a note on your own obligations (Articles 13 and 14); a checklist of verifications before making devices available; template registers of complaints, non-conformities and recalls; model clauses for your suppliers; support with EUDAMED registration for importers. €2,900 excl. VAT for a single role with no work on the product, up to €4,900 excl. VAT for both roles or a relabelled or repackaged product. It does not include reviewing your existing contracts or assistance during an inspection.

  • Supply chain contracts

    An analysis of your distribution, subcontracting or mandate contracts against the allocation of obligations set by the Regulation, proposed clauses (liability, quality, vigilance, traceability, recalls) and one negotiation round with the counterparty. €6,000 excl. VAT for reviewing three existing contracts, up to €12,000 excl. VAT for drafting two contracts. Beyond the included round: time spent, agreed in writing. It does not include contracts governed by a foreign law.

  • EU market access

    The allocation of roles (manufacturer, authorised representative, importer, distributors), the qualification and class of the product under EU law, the specifications for the authorised representative and a comparison of the offers received, a review of the written mandate, an entry timetable, three video calls and deliverables in English. €9,000 excl. VAT for a simple product, up to €15,000 excl. VAT for a range, software or artificial intelligence, or an in vitro diagnostic. I do not act as authorised representative; differences with a status obtained outside the Union are presented as a factual comparison of requirements, not as an opinion on foreign law.

  • Watch and direct line

    A monthly watch note on what changes for your product and your role (texts, MDCG guidance, positions of the authorities, progress of the reform), and your questions in writing or by phone, answered within two working days. Two hours a month for €490 excl. VAT, four hours for €990 excl. VAT.

  • Deadline follow-up

    In addition: your regulatory calendar kept up to date (end of transition, certificates, renewals, EUDAMED), an alert before each deadline setting out what must be under way by then, answers within one working day and an annual scope review. Three hours and a quarterly call for €750 excl. VAT, eight hours and a monthly call for €2,000 excl. VAT.

  • Rules common to subscriptions

    The watch note is not counted against the time included; video calls are. The time included covers questions and guidance; deliverables (written opinion, note, contract) fall under a package. Unused hours do not carry over from one month to the next. No minimum term, one month's notice.

If we agree, the chosen service is set out in a signed fee agreement before any work begins. It sets the scope and its exclusions, the number of meetings and rounds of comments, and the firm price within the stated range. It is preceded by a conflict-of-interest check. Assignments that cannot be scoped in advance (an inspection by an authority, a position to defend before a notified body, a growth transaction) are quoted separately. Amounts exclude VAT: VAT at 20% is added for clients established in France; for a business client established in another EU Member State, it is self-assessed by the customer under the reverse-charge mechanism.

Portrait of François Césure

Who establishes concordance

“I spent more than ten years as general counsel in the healthcare industry before becoming a lawyer. A CE marking is won in the technical file. It is often lost in the texts: a qualification poorly framed, a deadline misread, a contract that says nothing.”
François Césure
  • AvocatParis Bar, since 2012
  • General counselmore than ten years, healthcare industry
  • Regulationmaster's degree in health products regulation

Our terms

What is settled before any assignment

  • The test is not legal adviceThe report is an indicative preliminary analysis, based solely on your answers. Advice begins with the lawyer, under a fee agreement.
  • No promise of outcomeNeither CE marking nor a decision by an authority can be guaranteed. The commitment covers the means, the method, the scope and the timetable, in writing.
  • A price confirmed in writingThe scope, the exclusions and what triggers a quote are written down before work begins. No additional work without your agreement.
  • IndependenceI do not act as authorised representative and receive no remuneration from any third party. The advice serves your case alone.
  • Conflict-of-interest checkBefore any assignment. If there is a conflict, you are told, and the matter is not opened.
  • Your answers stay with youThe questionnaire runs in your browser. Only your email address and the summary of your report are sent to me.