{"id":1541,"date":"2026-09-14T21:10:06","date_gmt":"2026-09-14T19:10:06","guid":{"rendered":"https:\/\/helenaolbertova.com\/?page_id=1541"},"modified":"2026-09-14T21:16:53","modified_gmt":"2026-09-14T19:16:53","slug":"home","status":"publish","type":"page","link":"https:\/\/helenaolbertova.com\/cs\/","title":{"rendered":"Dom\u016f"},"content":{"rendered":"
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IVDR konzutantka na voln\u00e9 noze \u00b7 ji\u017en\u00ed Morava a pr\u00e1ce na d\u00e1lku<\/p>\n\n\n\n

Helena Olbertova, Ph.D.<\/p>\n\n\n\n

IVDR Compliance and EU Market Access for IVD Manufacturers<\/h1>\n\n\n\n

65+ IVD products certified across all device classes, A to D.<\/strong>
I solve IVDR problems hands-on for manufacturers. When the same problem keeps coming back, I turn it into a course or a template so anyone can solve it themselves.<\/p>\n\n\n\n

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Rezervujte si bezplatnou 30minutovou sch\u016fzku<\/a><\/div>\n\n\n\n
See What I Do<\/a><\/div>\n<\/div>\n<\/div>\n\n\n\n
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\"Helena<\/figure>\n<\/div>\n<\/div>\n\n\n\n
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65+<\/strong>IVD Certifikace<\/span><\/p>\n<\/div>\n\n\n\n

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400+<\/strong>Star\u0161\u00ed prost\u0159edky (legacy devices)<\/span><\/p>\n<\/div>\n\n\n\n

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6+<\/strong>Let zku\u0161enost\u00ed<\/span><\/p>\n<\/div>\n\n\n\n

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Ph.D.<\/strong>Experiment\u00e1ln\u00ed onkologie a n\u00e1dorov\u00e1 biologie<\/span><\/p>\n<\/div>\n\n\n\n

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Classes A to D<\/strong>V\u0161echny t\u0159\u00eddy IVD<\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n

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Where to Start<\/p>\n\n\n\n

Four Situations, One of Them Is Probably Yours<\/h2>\n\n\n\n

Almost everyone who contacts me arrives in one of these four situations. Find yours and go straight to what applies. Clients regularly describe the same relief afterwards: finally knowing where to start, what is expected, and which gaps to close first.<\/p>\n\n\n\n

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You Are Building Your First IVD<\/h3>\n\n\n\n

A startup or a spin-off with strong science and no regulatory function. You need to know what IVDR will demand before you design yourself into a corner. Intended purpose, classification, and evidence strategy decided early cost a fraction of what they cost later.<\/p>\n\n\n\n

Certification projects and early-stage advisory<\/a><\/p>\n<\/div>\n<\/div>\n\n\n\n

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Your Legacy Portfolio Needs to Transition<\/h3>\n\n\n\n

Products self-declared under IVDD now need a Notified Body, new documentation, and in many cases new performance data. The regulatory deadlines are only half of it. Once you sign with a Notified Body, the submission dates agreed in that plan become your real deadlines, and they usually sit well before the dates in the Regulation.<\/p>\n\n\n\n

See how a legacy transition runs<\/a><\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n

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Your Team Is One Person Doing Three Jobs<\/h3>\n\n\n\n

No budget for regulatory software, no prospect of hiring, and IVDR obligations running across the whole product lifecycle. Whatever we build has to fit inside the hours and the tools you already have, or it will not survive.<\/p>\n\n\n\n

See how this works in a small team<\/a><\/p>\n<\/div>\n<\/div>\n\n\n\n

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You Have Devices to Register in EUDAMED<\/h3>\n\n\n\n

Product data spread across labelling files, ERP, and technical documentation. Manual entry works, but once the portfolio grows it is neither the fastest nor the safest route: every screen is another chance to mistype a number, and errors in a database record are found late and corrected slowly.<\/p>\n\n\n\n

EUDAMED registration, two ways<\/a><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n

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Currently on the Agenda<\/p>\n\n\n\n

What IVD Manufacturers Are Working On<\/h2>\n\n\n\n

These are the items occupying most regulatory teams at the moment. I support all of them, now and in the years ahead as the transition continues.<\/p>\n\n\n\n

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Registrace v syst\u00e9mu EUDAMED<\/h3>\n\n\n\n

Devices placed on the EU market before 28 May 2026 are to be registered by 27 November 2026, and new devices before they are placed on the market. Registration continues as an ongoing obligation for every new product afterwards.<\/p>\n\n\n\n

XML batch upload or guided manual registration<\/a><\/p>\n<\/div>\n<\/div>\n\n\n\n

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Legacy Transition, Class B and A Sterile<\/h3>\n\n\n\n

Applications to a Notified Body are due by 26 May 2027, with certification through to the end of 2029. For most manufacturers this is the largest part of the portfolio, and the documentation work behind it runs for years.<\/p>\n\n\n\n

Legacy transition support<\/a><\/p>\n<\/div>\n<\/div>\n\n\n\n

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PPWR Packaging Compliance<\/h3>\n\n\n\n

Regulation (EU) 2025\/40 has applied since 12 August 2026. Packaging needs its own declaration of conformity and its own technical file, separate from the device DoC. I offer ready-to-fill templates in eight European languages for exactly this.<\/p>\n\n\n\n

PPWR templates<\/a><\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n

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Class C, Agreement Signed by 26 September 2026<\/h3>\n\n\n\n

Class C legacy devices whose application went in by 26 May 2026 now need a signed written agreement with the Notified Body before 26 September 2026. Miss that date and the extended transition period no longer applies to those devices.<\/p>\n\n\n\n

Notified Body selection and application support<\/a><\/p>\n<\/div>\n<\/div>\n\n\n\n

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Everything Already Running<\/h3>\n\n\n\n

Documentation for devices already under a Notified Body agreement, surveillance and post-market work on certified products, and new products still in development. Deadlines get the attention, but the portfolio you already sell and the products you are building next do not pause while you meet them.<\/p>\n\n\n\n

Certification projects and ongoing support<\/a><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n

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Free Mini-Course \u00b7 No Payment Required<\/p>\n\n\n\n

Who’s Who Under the IVDR<\/h3>\n\n\n\n

Not ready for a call? Start here instead. A short, structured tour through the roles that make the IVDR work: the four economic operators and the two authorities behind them. Who owns which obligation, how the roles connect, and the exact articles that define each one.<\/p>\n\n\n\n

Manufacturer duties including post-market surveillance, vigilance and the PRRC. The Authorised Representative as the EU gateway for non-EU manufacturers. The difference between importer and distributor, including Article 16. What Notified Bodies and Competent Authorities actually do.<\/p>\n\n\n\n

5 chapters \u00b7 Under 1 hour \u00b7 Quiz after each chapter \u00b7 Certificate on completion<\/strong>
Finish it and you receive a discount code toward the paid courses.<\/p>\n\n\n\n

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Start the Free Course<\/a><\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n
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Case Studies<\/p>\n\n\n\n

How This Works in Practice<\/h2>\n\n\n\n

Real projects from my own practice, described without company names, product names, or locations. They are the clearest way to show what I do and where I can help.<\/p>\n\n\n\n

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No Notified Body, Five Class C Devices<\/h3>\n\n\n\n

Readiness audit across QMS and technical documentation, classification with written rationale, three notified bodies approached and compared, application accepted and agreement signed. Six months.<\/p>\n\n\n\n

Read the full case<\/a><\/p>\n<\/div>\n<\/div>\n\n\n\n

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A Portfolio Measured in Hundreds of Products<\/h3>\n\n\n\n

A fixed audit date, roughly one working day per product, and automation built inside existing tools that stayed with the team for the waves that followed.<\/p>\n\n\n\n

Read the full case<\/a><\/p>\n<\/div>\n<\/div>\n\n\n\n

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34 IVDR Devices Registered in EUDAMED in 30 Minutes<\/h3>\n\n\n\n

Devices certified under the IVDR, one structured template, a review of the completed data, and a batch XML upload instead of weeks of manual entry.<\/p>\n\n\n\n

Read the full case<\/a><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n

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Reference<\/p>\n\n\n\n

Co \u0159\u00edkaj\u00ed klienti<\/h2>\n\n\n\n
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\u201eHelena prok\u00e1zala neoceniteln\u00e9 znalosti v oblasti regula\u010dn\u00ed strategie a dodr\u017eov\u00e1n\u00ed p\u0159edpis\u016f. Vypracovala jasn\u00e9 a praktick\u00e9 strategie implementace IVDR, vytvo\u0159ila efektivn\u00ed \u0161ablony a podporovala cel\u00fd proces od strategi\u00ed pod\u00e1n\u00ed \u017e\u00e1dost\u00ed a\u017e po \u00fasp\u011b\u0161n\u00e9 audity.\u201c<\/p>\nVedouc\u00ed odd\u011blen\u00ed QA\/QC<\/strong>
St\u0159edn\u011b velk\u00fd v\u00fdrobce<\/strong><\/cite><\/blockquote>\n\n\n\n

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\u201eD\u011bkujeme za konzultaci. B\u011bhem 60 minut jsme od v\u00e1s z\u00edskali odpov\u011bdi na na\u0161e kl\u00ed\u010dov\u00e9 ot\u00e1zky t\u00fdkaj\u00edc\u00ed se certifikace IVDR, v\u010detn\u011b jasn\u00fdch v\u00fdchoz\u00edch pokyn\u016f. D\u00edky tomu m\u016f\u017eeme efektivn\u011b pl\u00e1novat hodnocen\u00ed funk\u010dn\u00ed zp\u016fsobilosti. Oce\u0148ujeme p\u0159\u00edmou komunikaci, praktick\u00e9 tipy a materi\u00e1ly, kter\u00e9 jste n\u00e1m poskytla.\u201c<\/p>\nZakladatel\u00e9 startupu<\/strong>
Early-stage IVD company<\/strong><\/cite><\/blockquote>\n\n\n\n

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\u201eP\u0159edvypln\u011bn\u00fd checklist mi ji\u017e usnadnil pr\u00e1ci. D\u011bkuji za rychlou a precizn\u00ed podporu.\u201c<\/p>\nSpecialista pro regula\u010dn\u00ed z\u00e1le\u017eitosti<\/strong>
IVD manufacturer<\/strong><\/cite><\/blockquote>\n<\/div>\n<\/div>\n\n\n\n

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Newsletter<\/p>\n\n\n\n

IVDR updates, without the noise<\/h2>\n\n\n\n

Short practical notes on what is changing under the IVDR and what it means for your documentation: new MDCG guidance, EUDAMED steps, Notified Body expectations, and new courses when they open.<\/p>\n\n\n\n

Once a quarter at most.<\/strong> No sales sequences, no weekly noise, and you can leave with one click.<\/p>\n<\/div>\n\n\n\n

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