52
MDR Notified Bodies
19
IVDR Notified Bodies
6-18 months
Typical review timeline
The Transition That is Still Not Over
The MDR has been applicable since May 2021. The IVDR since May 2022. Under the old MDD, up to 80 Notified Bodies were designated. Under MDR, there are currently 52[Ga1.1][MR1.2]. Under IVDR, only 19. Fewer assessors, stricter requirements, longer queues.
Review timelines up to 18 months for a standard conformity assessment are now typical, longer for complex devices. The extended transition deadlines (December 2027 for higher-risk MDR devices, December 2028 for IVDR Class C, December 2029 for IVDR Class B and Class A sterile) were introduced because the system could not absorb the volume. Those deadlines tend to create a false sense of comfort, since the actual bottleneck is not the deadline but the Notified Body queue. Manufacturers who wait until 2027 to submit may find that capacity was already consumed. The practical response is to get the technical documentation right, submit early, and manage the NB process actively rather than waiting in line.
For IVDs, the pressure is more immediate. Most commercially significant IVDs moved up in classification under IVDR. Products that were previously self-certified now require Notified Body involvement. Class C legacy devices face a hard milestone: a formal application must be lodged with a Notified Body by 26 May 2026, with a signed written agreement in place by 26 September 2026. Miss those gates, and the extended transition period does not apply.
Meanwhile, EUDAMED is becoming operational. The four critical modules (actor registration, UDI/device registration, Notified Bodies and certificates, market surveillance) were declared functional in November 2025, triggering a six-month transition. From 28 May 2026, new devices must be registered before being placed on the market. Legacy devices must be registered by 28 November 2026. NB certificates issued before 28 May 2026 must be uploaded by 28 May 2027. Without an SRN through the actor module, none of the other submissions can proceed. This is a current problem and not one that can be dealt with later.
A Framework That is Still Being Rewritten
The MDR and IVDR continue to be amended, interpreted, and supplemented.
In December 2025, the European Commission published a major legislative proposal to simplify both regulations (COM(2025) 1023). The scope is significant: revised software classification rules under a rewritten Rule 11 that would allow more software to qualify as Class I[Ga3.1][MR3.2], the removal of the five-year certificate validity cap in favour of risk-proportionate periodic reviews, new pathways for breakthrough and orphan devices, expanded provisions for in-house devices, and structured pre-submission dialogues with Notified Bodies. Separately, a draft Commission Implementing Regulation on quality management and procedural requirements for Notified Body conformity assessment activities (published 12 December 2025) proposes standardised timelines covering both MDR and IVDR: 30 days for application review, 120 days for QMS audits, 90 days for product verification, 15 days to issue certificates.
If adopted, these changes would address some of the most persistent frustrations manufacturers face. But the proposal must pass through Parliament and Council, a process unlikely to conclude before late 2026 at the earliest. The current MDR and IVDR remain fully applicable in their existing form. The practical approach: comply with the current rules, track the reform, and be ready to take advantage of simplifications as they come into force.
This is the environment you and we work in every day. There is no help in simply summarising the regulation. What matters is knowing what the current requirements actually demand in practice, how individual Notified Bodies are interpreting them, and where the enforcement pressure is real versus theoretical.
Where the Real Difficulties Lie
Obviously, not all MDR/IVDR challenges are equal. Some are documentation exercises that take effort but have predictable outcomes. Others require judgment, experience, and sometimes creative problem-solving. Building a development roadmap that understands which is which is key to making sure the entire process runs as smoothly as possible.
Clinical evidence expectations have changed.
Under the old directives, many devices reached the market on the basis of literature-based clinical evaluation and equivalence claims. MDR raised the bar. MDCG 2020-5 made equivalence claims dependent on contractual access to the equivalent device’s technical documentation, which in practice means equivalence to a competitor’s device is rarely available. More manufacturers need to generate their own clinical data, either through clinical investigations or structured PMCF programmes. For legacy devices that were on the market for decades, this can feel disproportionate. The key is designing an evidence strategy that satisfies the Notified Body without overinvesting: using existing literature where it genuinely supports the clinical evaluation, targeting PMCF to the specific gaps, and reserving clinical investigations for where they are genuinely necessary.
Classification is not always straightforward.
MDR Annex VIII introduced more granular classification rules than the old directives. Rule 11 for software has been particularly contentious, producing classifications that many consider disproportionate to the actual risk. The Commission’s December 2025 proposal would rewrite Rule 11 to allow more software to qualify as Class I, but that change is not yet law. Borderline products (e.g., device vs. medicinal product, device vs. cosmetic) continue to require careful analysis and sometimes competent authority engagement. Getting the classification wrong can be expensive. Thus, getting it right early saves months and significant cost downstream.
Notified Body interactions reward preparation.
The quality of the initial submission determines the review timeline. A complete technical documentation that anticipates the NB’s questions can clear in one review cycle. A submission with gaps, inconsistencies between the GSPR checklist and the supporting evidence, or a clinical evaluation that does not meet MDCG expectations triggers multiple rounds of questions. Each round adds months. The difference between a 6-month and an 18-month certification often comes down to submission quality. This is where experience with specific Notified Bodies and their review patterns makes a measurable difference.
Increased expectations on IVDR performance evaluation.
With the majority of IVDs previously being subject to self-declaration, performance evaluation – both analytical and clinical – has often been taken lightheartedly. With IVDR, performance data has to live up to the state-of-the-art (e.g. CLSI guidelines on analytical performance) and meet Notfieid Body expectations. Knowing what NBs actually look for, and structuring the evidence accordingly, avoids the most common rounds of rework.
What We Bring to Device and IVD Work
We have worked in device and IVD regulation with dedicated teams for over 15 years, covering regulatory, preclinical, clinical, quality, and technical disciplines.
Three things distinguish how we work:
Dedicated specialist teams.
We have three device-focused teams, each with regulatory, non-clinical/biocompatiblity, clinical, quality, and technical experts working together: a medical device and combination products team, an IVD team, and a software/digital health/active medical device team. We are not generalist regulatory experts who also do device work but are experts who have spent our entire working lives in regulatory affairs of the medtech industry.
We compile and submit and do not just advise.
We write the technical documentation, prepare the GSPR checklist, structure the NB submission package, handle the review questions, and manage the process through to certificate issuance. We build the risk management files (ISO 14971), run usability engineering programmes (IEC 62366-1), ensure software lifecycle documentation (IEC 62304, IEC 81001-5-1) meets the standard[Ga8.1][MR8.2], manage development and design control processes, evaluate biocompatibility (ISO 10993), and perform clinical evaluation (MEDDEV 2.7/1 REV.4)The same team that identifies a gap is then also the team that helps closing it.
Global reach through regulanet®.
EU CE marking is often only the first step. We coordinate international device registrations through our global network: FDA 510(k), De Novo, and PMA pathway support for the US; Health Canada licensing; TGA registration for Australia; NMPA for China; MDSAP coordination. A global technical documentation is adapted and not rewritten for each market.
Across the Development Journey
Device development does not follow the same linear pathway as pharmaceutical development, but it moves through recognisable phases where different regulatory and quality disciplines become critical.
Discovery & Concept
Determine whether the product is a medical device. Classify under MDR or IVDR. Assess the conformity assessment route. Define the clinical evidence strategy early, because it shapes everything downstream.
Preclinical & Biocompatibility
Biocompatibility evaluation per ISO 10993, material characterization, toxicological assessment, and preclinical testing. Includes design verification and bench/performance testing. For IVDs: analytical performance studies. For software: continued implementation of IEC 62304 and cybersecurity requirements.
Design & Development
Structured design control in accordance with ISO 13485 (and IEC 62304 for software). Includes design planning, inputs/outputs, architecture, and traceability linking requirements, risk management, and clinical evidence. This phase builds the foundation of the technical documentation and ensures the product is developed in a controlled, auditable manner.
Clinical
Clinical investigations (MDR Article 62), performance studies (IVDR), usability validation (summative testing), PMCF/PMPF planning. Clinical evidence integration into the technical documentation.
Regulatory Submission & Approval
Notified Body submission, review management, response to questions and conditions, certificate issuance. For IVDs: EU Reference Laboratory involvement for Class D. EUDAMED registration and UDI assignment.
Launch & Market Access
Declaration of Conformity, labelling finalisation, international registrations (FDA, Health Canada, TGA, others via regulanet®). Supply chain and distribution readiness.
Post-Market & Lifecycle Management
Technical documentation maintenance, design change assessments, NB surveillance and re-certification, PMS/PMCF/PMPF execution, device vigilance reporting. Regulatory obligations continue for as long as the product remains on the market.
Bringing a Device or IVD to the EU Market, Managing an MDR or IVDR Transition, or Planning an International Registration?
Tell us about your product and where you are in the process, and we will outline how we can help.
Speak with an ExpertFrequently Asked Questions (FAQ)
What is the realistic timeline from technical documentation submission to CE certificate?
For a Class IIb device under Annex IX, expect 6 to 18 months from first NB submission to certificate issuance. The range reflects submission quality, device complexity, and the specific NB's current workload. A well-prepared submission with a complete GSPR mapping, coherent clinical evaluation, and structured risk management file will move faster. A submission with gaps triggers question rounds, each adding two to four months. We manage the entire cycle and aim to get it right first time.
How do you select a Notified Body?
Scope of designation (not all NBs cover all device types), current queue times, experience with similar devices, geographic preference, and fee structure. We maintain current knowledge of NB capacity across the major designated bodies and advise on the choice that best balances timeline and review quality.
We have devices on the market under MDD certificates. What should we be doing now?
If you have not already submitted to a Notified Body for MDR certification, start now. The extended deadlines (December 2027 for higher-risk, December 2028 for medium/lower-risk) required that a contract with a NB was signed before the applicable milestone date. Even with a contract in place, NB capacity means your submission will sit in a queue. The earlier you submit, the more control you have over the timeline. We assess the portfolio, prioritise by expiry date and commercial importance, and manage the transition plan.
What is the IVDR Class C milestone in May 2026?
A formal application must be lodged with a Notified Body by 26 May 2026. A signed written agreement must be in place by 26 September 2026. These are not soft targets. Missing them means losing eligibility for the extended transition period, which could force the product off the EU market.
Can the EU technical documentation be used for international registrations?
Yes. The MDR technical documentation is typically the most comprehensive device regulatory file, and it serves as the foundation for other markets. For FDA 510(k), we extract the relevant performance data and build the predicate device comparison. For Health Canada, TGA, and other markets, the adaptations differ but the core evidence base is the same. We coordinate international registrations through regulanet®.
How does the December 2025 Commission proposal affect us?
Not yet. The proposal must pass through Parliament and Council, and changes are expected during that process. Adoption before late 2026 is unlikely. Plan against the current MDR and IVDR. Track the reform. Be ready to benefit from simplifications as they take effect. The most impactful proposed changes include the removal of the five-year certificate cap, revised software classification (Rule 11), structured NB dialogues with standardised timelines, and new pathways for breakthrough and orphan devices.
What about the UK market? Do we need UKCA marking?
In February 2026, the MHRA opened a consultation (closing 10 April 2026) on indefinitely recognising CE-marked devices in Great Britain. Around 90% of devices on the GB market currently rely on CE marking. If adopted, CE-marked devices compliant with EU MDR or IVDR could remain on the GB market without separate UKCA certification. Northern Ireland continues to follow EU rules regardless. We track both frameworks and advise on the most efficient market access strategy for each situation.