IVDR konzutantka na volné noze · jižní Morava a práce na dálku
Helena Olbertova, Ph.D.
IVDR Compliance and EU Market Access for IVD Manufacturers
65+ IVD products certified across all device classes, A to D.
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.
Where to Start
Four Situations, One of Them Is Probably Yours
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.
You Are Building Your First IVD
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.
Your Legacy Portfolio Needs to Transition
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.
Your Team Is One Person Doing Three Jobs
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.
You Have Devices to Register in EUDAMED
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.
Currently on the Agenda
What IVD Manufacturers Are Working On
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.
Registrace v systému EUDAMED
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.
Legacy Transition, Class B and A Sterile
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.
PPWR Packaging Compliance
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.
Class C, Agreement Signed by 26 September 2026
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.
Everything Already Running
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.
Free Mini-Course · No Payment Required
Who’s Who Under the IVDR
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.
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.
5 chapters · Under 1 hour · Quiz after each chapter · Certificate on completion
Finish it and you receive a discount code toward the paid courses.
Case Studies
How This Works in Practice
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.
No Notified Body, Five Class C Devices
Readiness audit across QMS and technical documentation, classification with written rationale, three notified bodies approached and compared, application accepted and agreement signed. Six months.
A Portfolio Measured in Hundreds of Products
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.
34 IVDR Devices Registered in EUDAMED in 30 Minutes
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.
Reference
Co říkají klienti
„Helena prokázala neocenitelné znalosti v oblasti regulační strategie a dodržování předpisů. Vypracovala jasné a praktické strategie implementace IVDR, vytvořila efektivní šablony a podporovala celý proces od strategií podání žádostí až po úspěšné audity.“
Vedoucí oddělení QA/QC
Středně velký výrobce
„Děkujeme za konzultaci. Během 60 minut jsme od vás získali odpovědi na naše klíčové otázky týkající se certifikace IVDR, včetně jasných výchozích pokynů. Díky tomu můžeme efektivně plánovat hodnocení funkční způsobilosti. Oceňujeme přímou komunikaci, praktické tipy a materiály, které jste nám poskytla.“
Zakladatelé startupu
Early-stage IVD company
„Předvyplněný checklist mi již usnadnil práci. Děkuji za rychlou a precizní podporu.“
Specialista pro regulační záležitosti
IVD manufacturer
Spojme se
Budete komunikovat přímo se mnou. Žádný prodejní tým, žádné zprostředkování. Pokud hledáte spolehlivého a zkušeného partnera, který vám pomůže posunout váš IVDR projekt vpřed, pojďme si otevřeně promluvit o tom, kde se právě nacházíte a co je třeba udělat dál.