[{"data":1,"prerenderedAt":566},["ShallowReactive",2],{"magazine:quality-control":3,"magazine:quality-control:related":504,"city-stats":512},{"id":4,"title":5,"author":6,"body":7,"cities":475,"description":480,"draft":481,"extension":482,"format":483,"meta":484,"navigation":485,"path":486,"published":487,"readingMinutes":488,"related":489,"section":492,"seo":493,"services":494,"sitemap":499,"sourcesVerified":500,"standfirst":501,"stem":502,"__hash__":503},"magazine/magazine/quality-control.md","Europe regulates the implant and the dentist. Nobody regulates the decision.",null,{"type":8,"value":9,"toc":460},"minimark",[10,14,17,22,25,39,51,54,59,62,65,69,72,78,84,87,91,94,97,105,109,112,120,124,132,236,239,243,246,249,252,255,259,262,265,297],[11,12,13],"p",{},"Dental care gets inspected in four separate places: the things that go into your mouth, the room they are used in, the person holding them, and the decision about what to do. Those four layers are regulated to very different degrees. Two of them are essentially European and identical everywhere. One is national but technically convergent. One is not really regulated anywhere at all, and it happens to be the one that decides whether you are happy in ten years.",[11,15,16],{},"Sorting the layers is more useful than sorting the countries.",[18,19,21],"h2",{"id":20},"the-device-one-rulebook-and-switzerland-is-outside-it","The device: one rulebook, and Switzerland is outside it",[11,23,24],{},"Implants, ceramics, alloys, bonding agents, chairs and scanners are medical devices under Regulation (EU) 2017/745, the MDR. Same classification rules, same notified bodies, same clinical evidence requirements, same vigilance reporting, in Budapest and Baden-Württemberg alike. An implant system sold in Kraków is the same certified product sold in Zurich, usually from the same handful of manufacturers.",[11,26,27,28,33,34,38],{},"The counterintuitive part is your ",[29,30,32],"a",{"href":31},"/services/crowns","crown",". Prosthetic work made by a dental laboratory for one named patient is a ",[35,36,37],"strong",{},"custom-made device"," under Article 2(3) and Annex XIII of the MDR. Custom-made devices are not CE marked and never have been. They carry no UDI and are not registered in EUDAMED. Instead the lab issues a written statement naming the manufacturer, the manufacturing sites and the patient, keeps it for ten years, fifteen for implantable work, and maintains a quality and risk management system behind it. Class III implantable custom devices are the exception: those do require a notified body.",[40,41,43],"mag-panel",{"title":42},"Nobody's crown carries a CE mark",[11,44,45,46,50],{},"So nobody's crown carries a CE mark. Not in Milan, not in Bern. What exists instead is ",[29,47,49],{"href":48},"/magazine/whats-in-the-box","a traceable statement with a name on it",". Asking for that statement is a reasonable question in any of the seven countries, and the answer tells you which laboratory did the work.",[11,52,53],{},"Switzerland is the odd one out, and not in the direction most people assume. The Swiss Medizinprodukteverordnung is written to track the MDR closely, but the mutual recognition agreement with the EU was never updated in May 2021. Switzerland is now a third country for device purposes. Swiss manufacturers face the EU market like any other non-EU manufacturer, EU manufacturers need a Swiss authorised representative to sell here, and Swissmedic lost its access to the European device database. Switzerland accepts CE-marked devices unilaterally. It no longer sits inside the system that produces them.",[55,56,58],"h3",{"id":57},"amalgam-is-the-clearest-example","Amalgam is the clearest example",[11,60,61],{},"Under Regulation (EU) 2024/1849, dental amalgam has been banned for general use across the EU since 1 January 2025, with narrow exceptions for documented medical need. A temporary derogation for member states where amalgam was the only substantially reimbursed filling material expired on 30 June 2026. Manufacture and import into the EU stopped on 1 July 2026. Switzerland restricts amalgam where a mercury-free alternative is available, and real-world use is estimated below one percent, but it has not banned it.",[11,63,64],{},"The material rule is currently stricter in all six destinations than it is at home.",[18,66,68],{"id":67},"the-room-national-enforcement-near-identical-substance","The room: national enforcement, near-identical substance",[11,70,71],{},"Sterilisation and imaging are the two things patients actually worry about. Both are governed nationally, and both have converged to the point where the texts read like translations of each other.",[11,73,74,77],{},[35,75,76],{},"Reprocessing."," In Germany, section 8 of the Medizinprodukte-Betreiberverordnung, recast in February 2025, requires validated procedures with demonstrable results, and following the joint KRINKO and BfArM recommendation creates a presumption of compliance. Health offices carry out practice inspections, and the recurring findings are the same everywhere: missing work instructions, undocumented validation, unclear responsibilities. In Switzerland, Article 72 of the MepV requires the same thing in almost the same words, validated processes inside a quality management system with recorded sterilisation data, and the cantons have been checking reprocessing in medical and dental practices since 1 July 2011. Poland and Hungary run sanitary inspection alongside the licensing regime described below.",[11,79,80,83],{},[35,81,82],{},"Imaging."," The six EU destinations operate under Directive 2013/59/Euratom: every exposure must be justified and optimised, diagnostic reference levels apply, staff training is prescribed. Switzerland rebuilt its radiation ordinance on the same ICRP basis with effect from 1 January 2018. An X-ray installation needs a federal licence to be set up and run, and operating a CBCT scanner requires a specific additional qualification on top of the dental degree.",[11,85,86],{},"This layer is where the practical answer is genuinely boring: the requirements are equivalent, and what varies is how diligently a given practice documents them. That is a clinic-level variable, not a country-level one.",[18,88,90],{"id":89},"the-person-automatically-equivalent-by-law","The person: automatically equivalent, by law",[11,92,93],{},"Directive 2005/36/EC gives dental practitioners automatic recognition. A qualification listed in Annex V must represent at least five years of full-time study and at least 5,000 hours, and every other member state must then treat it as if it had issued the diploma itself. There is no aptitude test, no equivalence assessment, no discretion. Switzerland participates through the agreement on free movement of persons.",[11,95,96],{},"This is a stronger statement than most patients realise. A Hungarian or Polish dental degree is not \"recognised in Switzerland after review\". It is legally equivalent for access to the profession, and thousands of dentists practising in Germany and Switzerland hold exactly those degrees.",[11,98,99,100,104],{},"What automatic recognition does not do is say anything about the individual. It certifies a floor. Every one of the seven countries maintains a ",[29,101,103],{"href":102},"/magazine/verify-a-dentist","register of licensed practitioners",", and every one of them will confirm whether a named person is on it.",[18,106,108],{"id":107},"the-decision-regulated-nowhere","The decision: regulated nowhere",[11,110,111],{},"There is no European rule about when an implant is indicated, how much enamel may be removed for a veneer, whether a worn tooth gets a crown or an onlay, or how many units a bridge should span. Article 168 of the Treaty leaves the organisation and delivery of healthcare to the member states, and the member states in turn leave the clinical decision to the profession. Guidelines exist, published by national societies and specialist associations, and they are guidelines.",[11,113,114,115,119],{},"Everything that is genuinely harmonised sits upstream of the decision that matters. This is the honest finding of the whole comparison: the differences worth investigating are ",[29,116,118],{"href":117},"/discover","between clinics, not between countries",".",[18,121,123],{"id":122},"before-or-after-two-different-philosophies","Before or after: two different philosophies",[11,125,126,127,131],{},"Where the seven do diverge is in ",[128,129,130],"em",{},"when"," the state intervenes. Broadly, Southern and Central Europe license the premises. Germany and Switzerland license the person.",[133,134,136],"mag-table",{"caption":135},"Who is licensed, and what backs a claim",[137,138,139,155],"table",{},[140,141,142],"thead",{},[143,144,145,149,152],"tr",{},[146,147,148],"th",{},"Country",[146,150,151],{},"Practice or clinic",[146,153,154],{},"Liability cover",[156,157,158,170,181,192,203,214,225],"tbody",{},[143,159,160,164,167],{},[161,162,163],"td",{},"Switzerland",[161,165,166],{},"Cantonal licence for the practitioner, time-limited and renewed against evidence of continuing education and insurance",[161,168,169],{},"Compulsory under Art. 40 lit. h MedBG. No statutory sum. Zurich guidance treats CHF 5 million as the normal floor",[143,171,172,175,178],{},[161,173,174],{},"Germany",[161,176,177],{},"Approbation plus chamber membership; premises subject to hygiene inspection",[161,179,180],{},"Compulsory through state-level professional law",[143,182,183,186,189],{},[161,184,185],{},"Italy",[161,187,188],{},"Regional health authorisation for the practice, with a named clinical director",[161,190,191],{},"Compulsory under the Gelli-Bianco law (24/2017), with ten years of retroactive cover and ten years of run-off",[143,193,194,197,200],{},[161,195,196],{},"Spain",[161,198,199],{},"Authorised and registered as a health centre (type C.2.5.1). The authorisation is displayed on the premises and the register is public",[161,201,202],{},"Compulsory under Art. 46 of Ley 44/2003, for individual professionals and for the clinic as a legal entity",[143,204,205,208,211],{},[161,206,207],{},"Hungary",[161,209,210],{},"Operating licence per site. It cannot be issued without liability insurance",[161,212,213],{},"Compulsory. If the policy lapses, the insurer must notify the authority, which withdraws the licence",[143,215,216,219,222],{},[161,217,218],{},"Poland",[161,220,221],{},"Entry in the register of entities performing medical activity",[161,223,224],{},"Compulsory, with statutory minimum sums of EUR 75,000 per event and EUR 350,000 in aggregate. Many practices insure above the floor",[143,226,227,230,233],{},[161,228,229],{},"Greece",[161,231,232],{},"Practice permit via the regional authority and the local dental association",[161,234,235],{},"Required. The clearest legal source is Article 4 of the cross-border directive itself, and dental associations organise group cover",[11,237,238],{},"The Hungarian construction is the tightest link between the two philosophies anywhere in the group. Insurance is not a parallel obligation, it is a condition of the licence, and losing it closes the practice.",[55,240,242],{"id":241},"the-eu-has-quietly-built-a-floor-under-the-ex-post-side","The EU has quietly built a floor under the ex-post side",[11,244,245],{},"Directive 2011/24/EU, on patients' rights in cross-border healthcare, obliges every EU and EEA state to ensure a system of professional liability insurance or an equivalent guarantee for treatment on its territory. It also obliges the provider to tell you about that cover, along with its authorisation status, prices and complaints procedures, and it requires each country to run a national contact point that will answer questions about a specific provider's right to practise.",[11,247,248],{},"That is a disclosure right, and it is the single most underrated thing the EU does in this field. In Greece it is close to being the operative source of the insurance obligation. Everywhere else it converts an existing national duty into something a foreign patient can actually ask about and expect an answer to.",[11,250,251],{},"Switzerland has no equivalent. Swiss dentists must carry insurance and the canton verifies it at licence renewal, which is a real ex-ante check and arguably a firmer one than most. But there is no statutory right for a Swiss patient to be told the sum insured, and no national contact point standing behind the question.",[11,253,254],{},"Which produces the inversion worth sitting with. Switzerland front-loads its control onto the individual practitioner and keeps it there. The EU spreads control across the product, the premises and a written disclosure duty, and then, in Italy, keeps the policy answering claims for a decade after it ends. Neither is obviously better. They fail differently, and they are legible in different places.",[18,256,258],{"id":257},"the-short-version","The short version",[11,260,261],{},"Three of the four layers are effectively settled. The device rules are one European rulebook that six of these seven countries sit inside and Switzerland now sits outside. The room is governed nationally by texts that read like translations of each other. The practitioner is covered by automatic recognition, which is a legal equivalence rather than an assessment. On all three, the country is close to the wrong question.",[11,263,264],{},"The fourth layer is the one that decides whether you are happy in ten years, and nobody regulates it anywhere. That is not a gap between Switzerland and the destinations. It is a gap in all seven, and it is where the questions below are aimed.",[266,267,269],"mag-close",{"title":268},"Questions that have answers",[270,271,272,279,285,291],"ol",{},[273,274,275,278],"li",{},[35,276,277],{},"Who made the lab work, and can I see the statement?"," Every prosthetic device in Europe comes with an Annex XIII statement naming the manufacturer and the manufacturing site. It exists. It is not a special request.",[273,280,281,284],{},[35,282,283],{},"What is the registration number, and which register holds it?"," Answerable in all seven countries, and verifiable independently.",[273,286,287,290],{},[35,288,289],{},"Is the clinic itself authorised, and where is that recorded?"," In Spain, Italy, Hungary and Poland there is a facility-level entry to point at. In Spain the authorisation hangs on the wall and the registry number appears in the clinic's advertising.",[273,292,293,296],{},[35,294,295],{},"What happens to the insurance in year five?"," The useful detail is not the headline sum, it is retroactivity and run-off. An Italian policy must answer claims made ten years after it ends. Ask what yours does.",[298,299,300],"mag-sources",{},[301,302,303,316,326,336,346,356,369,382,408,430,443],"ul",{},[273,304,305,306,309,310],{},"European Union, ",[128,307,308],{},"Regulation (EU) 2017/745 on medical devices",", and MDCG 2021-3 on custom-made devices. Device classification, and why prosthetic work carries no CE mark. ",[29,311,315],{"href":312,"rel":313},"https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng",[314],"nofollow","EUR-Lex",[273,317,305,318,321,322],{},[128,319,320],{},"Regulation (EU) 2024/1849"," amending the mercury regulation. The amalgam ban and the derogation that expired on 30 June 2026. ",[29,323,315],{"href":324,"rel":325},"https://eur-lex.europa.eu/eli/reg/2024/1849/oj/eng",[314],[273,327,305,328,331,332],{},[128,329,330],{},"Directive 2005/36/EC",", Annex V point 5.3.2. The five-year, 5,000-hour training floor and automatic recognition. ",[29,333,330],{"href":334,"rel":335},"https://eur-lex.europa.eu/eli/dir/2005/36/oj/eng",[314],[273,337,305,338,341,342],{},[128,339,340],{},"Directive 2011/24/EU",", Article 4(2). The disclosure duty and the national contact points. ",[29,343,315],{"href":344,"rel":345},"https://eur-lex.europa.eu/eli/dir/2011/24/oj/eng",[314],[273,347,305,348,351,352],{},[128,349,350],{},"Directive 2013/59/Euratom",". Justification, optimisation and diagnostic reference levels for imaging. ",[29,353,315],{"href":354,"rel":355},"https://eur-lex.europa.eu/EN/legal-content/summary/setting-basic-safety-standards-for-exposure-to-ionising-radiation-from-2018.html",[314],[273,357,358,359,362,363,368],{},"Switzerland, ",[128,360,361],{},"Medizinprodukteverordnung"," (MepV), SR 812.213, ",[29,364,367],{"href":365,"rel":366},"https://www.fedlex.admin.ch/eli/cc/2020/552/de",[314],"Fedlex",", Art. 72 (Aufbereitung). Art. 72(2) requires reprocessing to use procedures that are suitable and validated to the state of science and technology, whose demonstrated effectiveness is assured traceably and reproducibly within a quality management system. With Art. 40 MedBG on cantonal practice authorisation, the Strahlenschutzverordnung (StSV) on imaging, and Swissmedic guidance on good reprocessing practice. Also the Swiss position on devices after the mutual recognition agreement lapsed.",[273,370,371,372,375,376,381],{},"Germany, ",[128,373,374],{},"Medizinprodukte-Betreiberverordnung"," (MPBetreibV) of 14 February 2025, in force from 20 February 2025, § 8(1) and (2), ",[29,377,380],{"href":378,"rel":379},"https://www.gesetze-im-internet.de/mpbetreibv_2025/__8.html",[314],"gesetze-im-internet.de",". § 8(1) requires reprocessing of reusable devices intended to be low-germ or sterile to use suitable validated procedures, so that the success of the process is demonstrably assured and patients, users and third parties are not endangered. § 8(2) presumes proper reprocessing where the joint RKI and BfArM recommendation on hygiene requirements is observed.",[273,383,384,385,388,389,394,395,398,399,402,403,407],{},"Italy, ",[128,386,387],{},"Legge 8 marzo 2017, n. 24"," (Gelli-Bianco), art. 11, ",[29,390,393],{"href":391,"rel":392},"https://www.normattiva.it/eli/id/2017/03/17/17G00041/CONSOLIDATED/20220730",[314],"Normattiva"," (Gazzetta Ufficiale n. 64, 17 March 2017). Cover must include a run-off period (",[128,396,397],{},"ultrattività",") for claims first made within ten years of the permanent cessation of professional activity, for events occurring while the policy was effective, including its retroactive period. Made operational by ",[128,400,401],{},"Decreto 15 dicembre 2023, n. 232",", art. 5(2), ",[29,404,393],{"href":405,"rel":406},"https://www.normattiva.it/atto/caricaDettaglioAtto?atto.dataPubblicazioneGazzetta=2024-03-01&atto.codiceRedazionale=24G00032&tipoDettaglio=multivigenza",[314]," (Gazzetta Ufficiale n. 51, 1 March 2024, effective 16 March 2024), which sets the minimum policy requirements and restates the rule.",[273,409,410,411,414,415,420,421,424,425,429],{},"Spain, ",[128,412,413],{},"Ley 44/2003, de 21 de noviembre, de ordenación de las profesiones sanitarias",", ",[29,416,419],{"href":417,"rel":418},"https://www.boe.es/buscar/act.php?id=BOE-A-2003-21340",[314],"BOE consolidated text",", and ",[128,422,423],{},"Real Decreto 1277/2003, de 10 de octubre",", which sets the general bases for authorising health centres, services and establishments and creates the national register, ",[29,426,419],{"href":427,"rel":428},"https://www.boe.es/buscar/act.php?id=BOE-A-2003-19572",[314],". Annex II lists dentistry as care unit U.44. Practitioner and facility authorisation.",[273,431,432,433,436,437,442],{},"Hungary, ",[128,434,435],{},"96/2003. (VII. 15.) Korm. rendelet"," on the general conditions for providing healthcare services and the operating licence procedure, ",[29,438,441],{"href":439,"rel":440},"https://njt.hu/jogszabaly/2003-96-20-22.49",[314],"Nemzeti Jogszabálytár",". The licence application must include the provider's liability insurance contract, or an undertaking to produce it within eight days of the licence becoming final, and the licence is withdrawn where the provider no longer holds valid cover. With NNK licensing guidance.",[273,444,445,446,449,450,453,454,459],{},"Poland, ",[128,447,448],{},"ustawa z dnia 15 kwietnia 2011 r. o działalności leczniczej",", art. 25, and the implementing ",[128,451,452],{},"rozporządzenie Ministra Finansów z dnia 29 kwietnia 2019 r."," on compulsory third-party liability insurance for entities carrying out medical activity, ",[29,455,458],{"href":456,"rel":457},"https://isap.sejm.gov.pl/isap.nsf/DocDetails.xsp?id=WDU20190000866",[314],"ISAP, Dziennik Ustaw"," (consolidated text Dz.U. 2025 poz. 272). Minimum sums of EUR 75,000 per event and EUR 350,000 in aggregate for the relevant categories of provider, including individual medical practice.",{"title":461,"searchDepth":462,"depth":462,"links":463},"",2,[464,468,469,470,471,474],{"id":20,"depth":462,"text":21,"children":465},[466],{"id":57,"depth":467,"text":58},3,{"id":67,"depth":462,"text":68},{"id":89,"depth":462,"text":90},{"id":107,"depth":462,"text":108},{"id":122,"depth":462,"text":123,"children":472},[473],{"id":241,"depth":467,"text":242},{"id":257,"depth":462,"text":258},[476,477,478,479],"budapest","baden-wurttemberg","krakow","milan","What gets checked in Switzerland and the six destination countries, who does the checking, and whether the check happens before your appointment or after.",false,"md","explainer",{},true,"/magazine/quality-control","2026-08-11","8",[490,491],"verify-a-dentist","whats-in-the-box","quality-control",{"title":5,"description":480},[495,496,497,498],"implants","crowns","veneers","bridges",{"loc":486},"2026-08","What actually gets checked in Switzerland, Hungary, Italy, Spain, Poland, Germany and Greece, who does the checking, and whether the check happens before your appointment or only after something has gone wrong.","magazine/quality-control","UPwC1Ce7xols5l2DihjsyCNQXa62eFnCV51Yq_7yghc",[505,509],{"path":102,"title":506,"section":507,"readingMinutes":508},"How to check a dentist abroad, and what nobody can check","due-diligence","14",{"path":48,"title":510,"section":492,"readingMinutes":511},"What's in the box","12",{"cities":513,"totals":558},[514,522,530,537,543,551],{"slug":515,"locality":516,"country":196,"clinic_count":467,"savings_percent":517,"price_modifier":518,"avg_rating":519,"review_count":520,"from_price_chf":521},"barcelona","Barcelona",65,0.35,4.58,59,53,{"slug":476,"locality":523,"country":207,"clinic_count":524,"savings_percent":525,"price_modifier":526,"avg_rating":527,"review_count":528,"from_price_chf":529},"Budapest",1,75,0.25,4.77,22,38,{"slug":478,"locality":531,"country":218,"clinic_count":524,"savings_percent":532,"price_modifier":533,"avg_rating":534,"review_count":535,"from_price_chf":536},"Krakow",72,0.28,4.72,18,42,{"slug":479,"locality":538,"country":185,"clinic_count":462,"savings_percent":539,"price_modifier":540,"avg_rating":541,"review_count":528,"from_price_chf":542},"Milan",55,0.45,4.86,68,{"slug":544,"locality":545,"country":229,"clinic_count":524,"savings_percent":546,"price_modifier":547,"avg_rating":548,"review_count":549,"from_price_chf":550},"athens","Athens",70,0.3,4.79,19,45,{"slug":477,"locality":552,"country":174,"clinic_count":524,"savings_percent":553,"price_modifier":554,"avg_rating":555,"review_count":556,"from_price_chf":557},"Baden-Württemberg",28,0.72,4.73,11,108,{"clinic_count":559,"avg_rating":560,"review_count":561,"avg_savings_percent":562,"max_savings_percent":525,"reservation_fee_min_chf":563,"reservation_fee_max_chf":564,"staff_count":565},9,4.7,151,61,100,200,39,1788616075819]