The end of the easy lane
For two decades under the old Medical Device Directive, "Class I" was shorthand for a manageable regulatory life. You kept your technical file, signed your Declaration of Conformity, registered with your national competent authority, and got on with selling. No Notified Body audit, no external certification, no six-figure consulting bill.
That world is over. Under the Medical Device Regulation (Regulation (EU) 2017/745), a surprising number of devices that used to sit comfortably in Class I have quietly been lifted into classes that require a Notified Body. The manufacturers making those devices - often SMEs with a handful of employees and no dedicated regulatory affairs function - are now sitting on a deadline that most of their larger peers are also struggling to meet. And that deadline is closer than it looks.
The up-classification trap
The first thing to understand about MDR is that the familiar four-class system (I, IIa, IIb, III) survived intact on paper, but the rules for what goes where changed substantially. Four mechanisms have pushed a meaningful share of yesterday's Class I devices into territory that now requires third-party certification.
Reusable surgical instruments - everything from forceps to retractors to specialised orthopaedic tools - now sit in a new sub-class called Class Ir. These remain Class I in name, but Article 52(7) now requires a Notified Body to assess the aspects related to reprocessing. This quietly added thousands of manufacturers across the Tuttlingen cluster in Germany, Mirandola in Italy, and similar concentrations in Central Europe to the NB queue.
Sterile devices (Class Is) and devices with a measuring function (Class Im) continue to require NB involvement for the sterility and metrology aspects respectively, but the scope of the technical documentation backing those aspects has expanded dramatically.
Software as a Medical Device took the hardest hit. Under MDCG 2019-11 (revised in June 2025), Rule 11 now classifies nearly all medical device software as Class IIa or higher. The Johner Institute has called this the "feared end for all Class I software." Only a vanishingly small category of software remains genuinely Class I under MDR.
Substance-based devices under the new Rule 21 - nasal sprays, lubricants, certain ocular drops - have moved from Class I into Class IIa, IIb, or even III depending on systemic absorption and intended use.
For manufacturers affected by any of these, the regulatory regime didn't just get stricter. It fundamentally changed. What used to be a self-declaration is now an externally audited conformity assessment with years of documentation behind it.
What Annex II actually asks for
The heart of MDR's technical documentation requirement lives in Annex II and Annex III, and the best way to describe it is "comprehensive." Annex II alone prescribes more than forty distinct elements grouped around device description, design and manufacturing information, a General Safety and Performance Requirements checklist mapping to the twenty-three sections of Annex I, a benefit-risk analysis anchored in ISO 14971:2019, and pre-clinical and clinical evidence that now includes a mandatory Clinical Evaluation Report for every class - including Class I. Annex III adds another fifteen-plus elements covering the post-market surveillance system: the PMS plan, the periodic safety update report (or the simpler PMS report for Class I), the post-market clinical follow-up plan, and trend reporting.
Two things make this more demanding than it looks on paper. The first is interdependence. Your intended purpose statement drives your clinical evaluation scope, which drives your PMS plan, which feeds back into your CER updates. If any of these drifts out of alignment during an audit, the whole dossier shakes. The second is volume. A complete Class I technical file routinely runs several hundred pages; a Rule 11 software file with proper verification and validation, biocompatibility, usability engineering, cybersecurity, and IFU translations crosses a thousand pages without difficulty.
The MDCG guidance stack a manufacturer now has to navigate runs to more than twenty documents, from the classification guidance in MDCG 2021-24 through the cybersecurity framework in MDCG 2019-16 to the recently updated PMS guidance in MDCG 2025-10. None of this existed in integrated form ten years ago. Most of it didn't exist five years ago.
The resource problem nobody likes to name
MedTech Europe's 2024 regulatory survey found that 91% of SME medical device manufacturers report difficulty securing qualified regulatory affairs staff. A typical Class I micro-SME employs half an FTE to two FTEs across combined quality and regulatory functions, and that person is usually wearing several other hats. External consultants fill the gap, but the consulting market is now capacity-constrained: the same survey found the average certification time from application to certificate is nearly twenty-two months, with more than half of that time spent waiting on the manufacturer to produce documents the NB has asked for.
The German industry associations - BVMed, VDGH, SPECTARIS, MedicalMountains - published a joint survey in autumn 2025 that captured the downstream effect. Seventy percent of BVMed members have withdrawn products from the EU market. Sixty-four percent of manufacturers of orphan devices have discontinued at least one product line. Fifty-eight percent of the products being withdrawn from the EU continue to be sold outside it, predominantly in the United States. The European Commission's own staff working document in late 2025 acknowledged that MDR's weaknesses "affect the availability of devices and the competitiveness of EU manufacturers - in particular of the many micro, small and medium-sized companies."
The bottleneck has also moved in an unexpected way. For several years the narrative was that Notified Bodies were the constraint: not enough of them, too slow to designate, overwhelmed by applications. That's no longer quite true. As of October 2025 there are fifty-one NBs designated under MDR, and Team-NB - the European association of medical device NBs - has been saying publicly that they have review capacity. Of nearly 32,000 applications lodged, only around 5,900 product certificates have been issued, and the top two reasons for application refusal are "application not complete" and "wrong qualification or classification of device." The friction in the system now lives on the manufacturer's side of the table.
The December 2028 wall
Regulation (EU) 2023/607, adopted in March 2023, bought the industry time. It extended the transition for legacy devices until 31 December 2027 for Class III and implantable Class IIb, and until 31 December 2028 for all other Class IIb, Class IIa, Class Is, Im and Ir - and critically, for every Class I device that has been up-classified under MDR. To benefit from the extension, manufacturers had to have an MDR-compliant quality management system in place by 26 May 2024 and a signed agreement with a Notified Body by 26 September 2024. The sell-off deadline was removed entirely.
December 2028 is the wall. Roughly six to ten thousand EU manufacturers - most of them SMEs, many of them making devices that under MDD required no external certification at all - need to have their Class Ir, Is, Im, or up-classified device through a full NB conformity assessment by that date. At current NB throughput, without a significant acceleration in dossier quality on the manufacturer side, a meaningful share of that cohort will not make it.
For the December 2025 EU simplification proposal currently in consultation - which would remove the five-year certificate cap, cut SME NB fees by half, and further widen Class I - the core content requirements of Annex II and III are not proposed to change. The work still has to be done. Some of the surrounding pressure might ease; the underlying documentation burden will not.
What a Class I manufacturer should be doing right now
The honest advice, if your device has been up-classified or involves a Notified Body assessment for the first time, is three-part.
Start earlier than feels reasonable. If you haven't already signed an NB agreement, the practical pipeline from first contact to certificate now runs eighteen to thirty months, and the clock has less than thirty months to run. The manufacturers who certify successfully tend to be the ones who stopped treating MDR as a future problem in 2023.
Invest in your technical documentation structure before you invest in content. The recurring failure modes NBs publish in their deficiency reports - weak intended-purpose statements, incomplete GSPR matrices, CERs that don't align with PMS plans, equivalence arguments that can't survive scrutiny - are almost always structural problems, not writing problems. A well-architected document skeleton with proper cross-referencing catches most of what auditors reject.
Use modern tools. The gap between a consultant billing by the hour to produce a bespoke dossier and a founder typing into a blank Word template is now being filled by AI-assisted drafting platforms grounded in the actual MDCG guidance and Annex II structure. Outputs still need qualified human review - the Person Responsible for Regulatory Compliance under Article 15 carries that - but the ratio of high-value review to low-value typing has shifted permanently. Artifakt sits in exactly this space: we're building regulatory intelligence tools that turn structured device inputs into audit-grade draft technical documentation, so that the RA function inside an SME can scale to the work MDR actually demands.
The Class I label is no longer a free pass. For several thousand European manufacturers, it's now the most exposed position in the regulation. The good news is that the deficiency patterns are well understood, the guidance is stable enough to build against, and the cost of getting this right is finally falling. Waiting another year is the one strategy that no longer works.