The MDR harmonises most of what it means to place a medical device on the EU market, but it deliberately leaves several areas to Member States — language of labelling and instructions for use, authorisation of clinical investigations, advertising, reimbursement, and restrictions on professional use. A CE mark gives you the right to place a device on the EU market, but each country you enter adds its own layer of national rules you must comply with.

By Tibor Zechmeister and Felix Lenhard.

TL;DR

  • The MDR is a Regulation, not a Directive, so most of it applies directly and uniformly across all EU Member States without national transposition.
  • MDR Article 10(11) explicitly delegates language requirements for labels and instructions for use to the Member State in which the device is made available.
  • Clinical investigation authorisation, advertising, reimbursement, and rules on professional use remain Member State competences and vary significantly between countries.
  • Germany's MPDG, France's Code de la santé publique, and Austria's MPG implement MDR-adjacent national rules that every startup must read before entering those markets.
  • A CE mark does not equal market access. It equals permission to make a device available, subject to each country's additional national requirements.

Where the MDR ends and national law begins

Founders read the MDR, see that it is a Regulation (directly applicable, no national transposition required), and conclude that once the CE mark is on the device and the Declaration of Conformity is signed, every EU market is open the same way. That conclusion is half right. The device is legally free to move across the internal market — that is exactly what Article 5 of Regulation (EU) 2017/745 establishes. But "placing on the market" in the MDR sense is not the same thing as "selling successfully in Germany, France, and Austria". The gap between those two phrases is filled by national law.

Recital 3 of the MDR is honest about this. It acknowledges that the Regulation harmonises conformity assessment but leaves certain matters — notably language, organisation of healthcare, and advertising — to Member States. The MDR deliberately carves out a zone of national competence. Startups that do not map that zone before they enter a second market lose months and sometimes lose deals.

I have seen founders ship a perfectly CE-marked Class IIa device into Germany, Austria, and France in the same quarter, and then discover that France requires the IFU in French, Germany requires registration in DMIDS, and Austria requires an Austrian-resident PRRC contact for certain product categories. None of that is in the MDR. All of it is mandatory.

What MDR actually says about Member State competences

The MDR is explicit in several places about what it leaves to national law.

Article 10(11) on manufacturer obligations states that manufacturers must ensure the device is accompanied by the information required under Annex I Section 23, "in an official Union language(s) determined by the Member State in which the device is made available to the user or patient". The Regulation harmonises the content of labels and IFUs; it leaves the language to the country.

Article 41 gives each Member State the obligation to designate the authority or authorities responsible for assessing applications for clinical investigations, and Chapter VI (Articles 62 to 82) sets the floor for what such an investigation must contain — but the actual authorisation procedure, timelines, and fees are national. Two sponsors running identical investigations in Germany and France face different paperwork, different ethics committee structures, and different starting clocks.

Article 7 prohibits misleading claims on labelling, IFUs, and promotional material at EU level, but the way advertising is regulated at country level — for example restrictions on advertising prescription devices to the general public, or rules about testimonials — sits in national law.

Reimbursement is not an MDR topic at all. Article 1(15) of the Regulation says explicitly that it does not affect national laws concerning the organisation, financing, or delivery of health services. Whether your device is reimbursed, under what code, and at what rate, is a decision made inside each national health system.

Restrictions on professional use — whether a device can only be used by a specific professional group, whether it requires a particular room classification, whether specific training is mandatory — are also national.

A worked example: one Class IIa device, three countries

Imagine a Class IIa software-driven medical device for early detection of a chronic condition. CE marked under MDR Annex IX with a Notified Body in the Netherlands. Declaration of Conformity signed, UDI assigned, Eudamed registration complete at EU level. The founder wants to sell it in Germany, France, and Austria.

Germany. The Medizinprodukterecht-Durchführungsgesetz (MPDG), in force since 26 May 2021, is the national law implementing MDR-adjacent rules in Germany. It requires registration in the national medical device information system DMIDS for certain device categories . German language for IFUs intended for lay users is generally required by BfArM's interpretation of Article 10(11). Advertising of medical devices to the general public is regulated by the Heilmittelwerbegesetz (HWG), which predates the MDR and still applies.

France. The Code de la santé publique, Livre II of Part Five, governs medical devices nationally. The ANSM (Agence nationale de sécurité du médicament) expects French language on labels and IFUs under Article 10(11), and maintains its own reporting obligations that sit alongside Eudamed. Advertising of medical devices in France is subject to prior review or control by ANSM for certain categories under Articles L.5213-1 and following of the Code .

Austria. The Medizinproduktegesetz 2021 (MPG 2021) is the Austrian national law accompanying the MDR. It requires a contact person resident in Austria for certain manufacturer obligations and confirms German as the required language under Article 10(11). BASG/AGES is the competent authority.

One device. One CE mark. Three translation obligations, three registration tasks, three advertising regimes, and three reimbursement conversations. None of those three conversations is an MDR conversation.

The Subtract to Ship playbook for multi-country national law

The point of Subtract to Ship is not to avoid work. It is to avoid work that does not ship the device. National law compliance is work that ships. Skip it and you cannot sell.

1. Treat national law as a market access module, not a regulatory module. Keep it separate from your technical file. Your Notified Body does not audit MPDG compliance and does not care about ANSM advertising approval. But your customers' procurement teams do, and so do the competent authorities when they inspect.

2. Build a country matrix before you sign your first distributor contract. Rows: your target countries. Columns: language requirements under Article 10(11), national registration obligations, clinical investigation authorisation if applicable, advertising regime, reimbursement pathway, PRRC or local contact requirements. Fill the matrix once per target country. Revisit it every six months.

3. Get the language requirement right at Annex I Section 23 time. If you know you will enter France, Germany, and Austria, build the IFU and label content for all three languages from the start. Do not retrofit translations after the Notified Body audit — the version control burden is brutal and every change triggers document control under your QMS.

4. Sequence markets, do not splatter. A founder who tries to open all 27 Member States simultaneously will do all 27 badly. Pick a beachhead. Get national law compliance clean in one country. Then clone the pattern to the next. The MDR work is done once. The national work is done 27 times, and each repetition gets cheaper.

5. Read the national law itself, not a summary. Have a regulatory lawyer or an experienced consultant translate the relevant articles of MPDG, Code de la santé publique, or MPG for you, and keep the reference in your files. National laws change. MDR does not replace them.

6. Ask local distributors what the real rules are. Distributors who have been placing devices in a market for fifteen years know which advertising claims get challenged, which hospital procurement processes demand which certificates, and which translations the tender bodies accept. That is unwritten knowledge. It is worth paying for.

Reality Check

  1. Do you have a written list of every target EU Member State for the next 24 months?
  2. For each target country, do you know which language the label and IFU must be in under Article 10(11)?
  3. For each target country, do you know whether a national registration is required in addition to Eudamed?
  4. If you plan clinical investigations, do you know which national competent authority authorises them and what the national timeline is?
  5. Do you know whether your device category is subject to restrictions on advertising to the general public in each target country?
  6. Do you have a named contact or legal adviser for national law questions in each target country, or are you relying on a generic EU summary?
  7. Is reimbursement strategy separated from your regulatory strategy in your business plan, and owned by someone who understands national health systems?

Frequently Asked Questions

Does a CE mark under MDR give me automatic access to all 27 EU Member States? It gives you the right to place the device on the EU market under MDR Article 5, meaning no further conformity assessment is needed. It does not exempt you from national language, registration, advertising, or reimbursement rules, which remain Member State competences.

Which language must my IFU be in? Whichever official Union language is required by the Member State where the device is made available, as stated in MDR Article 10(11). Most Member States require their own national language, and some require it even for devices intended exclusively for healthcare professionals.

Is Germany's MPDG part of the MDR? No. The MPDG is German national law that supplements the MDR and regulates areas the MDR leaves to Member States. It is mandatory for placing devices on the German market and enforced by BfArM and the Länder authorities.

Do I need a separate clinical investigation authorisation per country? Under MDR Chapter VI the authorisation remains a national decision. There is progress on coordinated assessment procedures, but for most startups today each country is a separate filing with its own timeline and ethics committee.

Is reimbursement regulated by the MDR? No. MDR Article 1(15) explicitly states the Regulation does not affect national laws on the organisation and financing of health services. Reimbursement is 100 percent national and must be planned separately from CE marking.

Can I advertise my CE-marked medical device freely across the EU? MDR Article 7 bans misleading claims at EU level, but national advertising rules — for example Germany's HWG or France's ANSM regime — impose additional restrictions, especially on advertising to lay users. Check per country before publishing.

Sources

  1. Regulation (EU) 2017/745 on medical devices, consolidated text. Articles 1(15), 5, 7, 10(11), 41, 62–82. Annex I Section 23. Recital 3.
  2. Medizinprodukterecht-Durchführungsgesetz (MPDG), Germany, in force 26 May 2021.
  3. Code de la santé publique, France, Livre II Part Five and Articles L.5213-1 et seq.
  4. Medizinproduktegesetz 2021 (MPG 2021), Austria.