MEDDEV Compliance Check eligibility
Menu
Services Markets Aesthetic devices Our team Safety reports Blog Check eligibility
MEDDEV BLOG

Practical answers for medical-device manufacturers entering the EU.

Source-led guidance on EC REP, MDR, IVDR, evidence, importers, EUDAMED and post-market responsibility.

Practical regulatory articles

Questions raised by manufacturers before an EU market-entry project begins. Every article identifies its author, publication date, reading time, official sources and a defined next step.

Australia · comparable overseas evidence

The certificate that works in both directions, and the obligation that does not

The TGA accepts certificates from EU notified bodies as comparable overseas evidence. What that changes for an Australian manufacturer, and what Article 11 still requires.

Marta Junosza-Szaniawska · 5 min read Read the article → Sequencing · seven markets

What a European certificate is worth outside the Union

Great Britain, Switzerland, Australia, Singapore, Israel, Türkiye and Ukraine all treat European conformity assessment as evidence, on different terms.

Mikołaj Junosza-Szaniawski · 6 min read Read the article → MDSAP · Annex IX MDR

One audit, five regulators, and still no route into the European Union

What the single audit programme is accepted for, why a European certificate cannot come from it, and how much of the gap the 2026 revision closed.

Marta Junosza-Szaniawska · 5 min read Read the article → Israel · recognition route

For an Israeli manufacturer, Europe is usually the first market, not the third

Israeli registration leans on approval in a recognised country, and a certificate that was never used to place a device on the EU market does not carry it.

Barbara Jęcka-Izdebska · 5 min read Read the article → Ukraine · Resolutions 759 and 758

Ukraine is rebuilding its rules on the MDR. The EU route just became cheaper to add

What the June 2026 technical regulations change for a Ukrainian manufacturer, why recognition runs one way, and where the twelve-month transitional period actually applies.

Mikołaj Junosza-Szaniawski · 6 min read Read the article → Türkiye · ÜTS and EUDAMED

Your ÜTS records answer most of the questions EUDAMED asks

Where the Turkish product tracking data maps onto a European device registration, which level is usually missing, and what carries no legal effect in the Union.

Barbara Jęcka-Izdebska · 5 min read Read the article → Switzerland · Article 11

A Swiss technical file is an MDR file. What is missing is an address in the Union

Why Swiss manufacturers arrive with the smallest evidence gap and the sharpest legal obstacle, and what a single shipment into the EU already triggers.

Marta Junosza-Szaniawska · 5 min read Read the article → Great Britain · SI 2024/1368

The 2025 UK surveillance rules built part of your MDR file already

The fifteen-day clock, the periodic safety update report and trend reporting map onto Articles 83 to 88 MDR. What still has to be built, and why the MHRA consultation changes the arithmetic.

Mikołaj Junosza-Szaniawski · 6 min read Read the article → Supply · Article 10a MDR

Discontinuing a product line in Europe now takes six months of notice

The notification duty added by the 2024 amendment, who receives it when the manufacturer sits outside the Union, and where quality systems usually fail to connect it.

Barbara Jęcka-Izdebska · 5 min read Read the article → Cybersecurity · Regulation (EU) 2024/2847

CRA reporting starts on 11 September 2026, and the device exemption is narrower than it reads

Article 2(2) excludes products covered by the MDR. It does not exclude the portal, the companion software without a medical purpose or the tools shipped around the device.

Mikołaj Junosza-Szaniawski · 6 min read Read the article → Clinical evidence · Article 61 MDR

From 510(k) to MDR: which parts of the submission survive the move

A predicate is not an equivalent device. What can be carried across from a US submission, and what has to exist before a notified body will progress the file.

Marta Junosza-Szaniawska · 7 min read Read the article → Sterile devices · Article 52(7) MDR

Sterile devices: the European evidence a US sterilization file often lacks

Sterility assurance for the STERILE claim, ethylene oxide residues, packaging validation and shelf life, and why a sterile class I device still needs a notified body.

Marta Junosza-Szaniawska · 6 min read Read the article → Quality systems · QMSR and MDR

QMSR compliance and MDR conformity: what still separates them

The FDA now incorporates ISO 13485:2016 by reference. The processes the Regulation adds on top, from the person responsible for regulatory compliance to the periodic safety update report.

Marta Junosza-Szaniawska · 6 min read Read the article → EUDAMED · Article 123(3) MDR

EUDAMED registration: what changed in May 2026 and what falls due in November

Which modules became mandatory, what the twelve-month obligation actually covers, and why a manufacturer outside the Union cannot obtain a single registration number alone.

Barbara Jęcka-Izdebska · 6 min read Read the article → Green claims · Directive (EU) 2024/825

Green Claims on Medical Devices: What Manufacturers Must Change by 27 September 2026

A practical review route for consumer-facing device claims, packaging statements, sustainability labels and climate-offset messaging.

Mikołaj Junosza-Szaniawski · 5 min read Read the article → EC REP · Article 11

Do I need an EU Authorized Representative?

A decision guide for manufacturers established outside the EU, including mandate timing and required documentation.

Marta Junosza-Szaniawska · 3 min read Read the article → Evidence mapping

Can FDA, Health Canada or Swissmedic records be reused in the EU?

What non-EU regulatory evidence can support EU compliance, and where MDR or IVDR-specific evidence remains necessary.

Marta Junosza-Szaniawska · 3 min read Read the article → Market entry

What must be ready before the first EU importer is appointed?

The minimum technical, registration and supply-chain documentation needed before placing a device on the EU market.

Barbara Jęcka-Izdebska · 3 min read Read the article → Classification

Why device classification should be checked before you request a quote

How classification changes conformity assessment, evidence requirements, timelines and representation review.

Marta Junosza-Szaniawska · 3 min read Read the article → Post-market

What does ongoing representation actually involve?

A practical overview of mandate maintenance, authority communication, vigilance and post-market responsibilities.

Barbara Jęcka-Izdebska · 3 min read Read the article → Risk review

When should an EU representative decline a mandate?

Warning signs that prevent a responsible representative from accepting or continuing a mandate.

Marta Junosza-Szaniawska · 3 min read Read the article →
EU market-entry navigator

Five questions turn a broad enquiry into a concrete review path. The result is immediate and does not require contact details.

Scroll to Top