Quality &amp; Regulatory Resources

MDR GSPR: what notified bodies really check in your technical documentation

Risk management, clinical evaluation, biocompatibility, cybersecurity, labelling: all the evidence in technical documentation exists to demonstrate conformity with the GSPRs of Annex I. It is also the first thing notified bodies examine.

MDR Annex III: technical documentation on post-market surveillance

Annex III is not about manufacturing but about post-market surveillance: a PMS plan compliant with Article 84, and a PSUR or PMS report depending on the class. Manufacturing information belongs to Annex II, Section 3.

12 min · Updated 15 September 2026 Read

Article 10 MDR: what obligations for the medical device manufacturer?

Corrective and Preventive Actions (CAPA): the most common audit mistakes

The lack of effectiveness verification is the most frequent gap among six mistakes that betray surface-level handling: root cause glossed over, immediate action disguised as corrective action, CAPAs never brought to management review.

The Clinical Evaluation Plan (CEP): what it is for and how to structure it

Notified bodies request this steering document before the CER itself, and immediately spot one that fails to identify the device's clinical gaps. Annex XIV, Part A of the MDR sets its mandatory content.

The Clinical Evaluation Report (CER): content, expected level of evidence, lifespan

The clinical evidence level expected rises with the class and the document is updated throughout the life cycle: the MDR sets no fixed frequency, but the PMCF evaluation report and the SSCP of implantable and class III devices are reviewed at least annually.

10 min · Updated 15 September 2026 Read

MDR and custom-made devices: a regime in its own right, often misapplied

Manufactured on request does not mean custom-made within the meaning of the Regulation: three cumulative conditions govern this status. The absence of CE marking does not mean the absence of MDR compliance — almost the entire Regulation still applies.

Drug/Device Combination Products: Which Regulatory Framework Applies?

Depending on whether the medicinal product or the device is the principal element, the product falls under Directive 2001/83/EC or Regulation (EC) No 726/2004, or under the MDR. In the ancillary configuration, the notified body consults the EMA or a national authority before any certificate.

11 min · Updated 15 September 2026 Read

Terminating an EC REP Mandate: Procedure, Timelines and Risks for the Manufacturer

The MDR sets no general notice period of 30, 60 or 90 days: the timetable is primarily contractual. What Article 12 does require is an agreement between the manufacturer, the incoming representative and, where practicable, the outgoing one, covering the dates, the transfer of documents and the handling of late complaints.

EC REP Strategy for a Non-EU Startup Seeking Access to the European Market

Access to the European market follows a precise sequence in which the EC REP conditions entry into EUDAMED. For a class IIa device, the realistic budget runs from 80,000 to 150,000 euros, far from startup estimates.

The EU declaration of conformity: mandatory content and common mistakes

Annex IV of the MDR sets a precise mandatory content, and a template inherited from Directive 93/42 no longer holds any value: citing standards withdrawn from the OJEU or signing without authority is enough to create a non-conformity.

EUDAMED: state of the modules and the 2026 obligation timeline

Since the decision was published in the OJEU on 27 November 2025, four EUDAMED modules have been officially declared functional by the European Commission. As of 28 May 2026, their use becomes mandatory. The Vigilance module is not yet concerned. Here is what this means in practice for manufacturers, authorised representatives and importers.

FMEA applied to medical devices: a relevant tool, but often poorly used

A poorly filled FMEA table is more dangerous than a blank one: it simulates an analysis while the real risks go unexamined. Overly generic failure modes, unjustified ratings and unverified controls drain the tool of its substance.

Risk Management for Medical Software: IEC 62304 and ISO 14971 Together

IEC 62304 sorts software into three safety classes, from A (no injury or damage to health possible) to C (death or serious injury possible), while ISO 14971 covers the whole device: the notified body expects both approaches to be linked in the file.

Use-Related Risk Management: IEC 62366-1 and Its Articulation with ISO 14971

IEC 62366-1 identifies foreseeable use errors while ISO 14971 assesses and controls the resulting risks. Technical documentation that addresses usability through the generic FMEA alone remains incomplete.

Instructions for Use (IFU) under the MDR: requirements of Annex I, Section 23

Section 23.4 of Annex I to the MDR lists 28 headings of mandatory information (points a to ab), from intended use to contraindications. IFU provided only in English on the French market amount to a non-conformity, as English is not an official language there.

Setting up an in-house regulatory function in a 20-person SME

A single person dedicated at 50 to 100 percent handles the QMS, post-market surveillance and the PRRC role under Article 15 of the MDR, yet the clinical evaluation of a class IIb device exceeds what in-house resource can take on alone.

12 min · Updated 15 September 2026 Read

ISO 13485:2016 vs the 2003 version: the 7 structural changes to remember

The migration from the 2003 version of ISO 13485 to the 2016 version has often been reduced to a documentary reformatting. This is a mistake that auditors spot without difficulty. Seven structural changes distinguish the two texts: risk-based approach extended to the QMS, software validation, strengthened supplier control, explicit integration of regulatory requirements. A QMS genuinely compliant with the 2016 version does not look like a pre-March 2019 one.

5 min · Updated 15 September 2026 Read

ISO 13485 calibration and verification: what auditors really check in section 7.6

ISO 13485 section 7.6 distinguishes traceable calibration from internal verification. What auditors try to catch is something else: the procedure when equipment is found out of tolerance. Because every measurement taken since the last valid calibration must be reassessed, and the products concerned identified.

From zero to ISO 13485 certified: steps, realistic timelines and indicative budget

Between kickoff and certificate, a realistic SME counts twelve to eighteen months and a budget of 40,000 to 80,000 euros once the internal cost of the quality manager, which many forget, is included.

Control of Nonconformities under ISO 13485: Procedure, Traceability, Closure

Clause 8.3 of ISO 13485 structures the handling according to when the nonconformity is detected, before or after delivery, and demands seamless traceability from finding to closure. A system nonconformity instead falls under the CAPA process of clause 8.5.2.

ISO 13485 internal audit: programme, auditor training, use of results

An internal audit that surfaces no nonconformity is suspicious: over the three-year certification cycle, the programme covers every process, requires independent auditors and closes with a CAPA whose effectiveness is verified.

ISO 13485 process mapping: where to start when you begin from scratch

The costliest mistake is shaping the QMS around the standard's requirements rather than the company's real activity: clause 4.1 expects a process map faithful to the ground, not a theoretical ideal.

ISO 13485:2016 confirmed in 2025: no revision under way, the topics to watch

Confirmed without changes on 31 October 2025 at the end of its systematic review, ISO 13485:2016 remains in force and no revision project is open. MDR alignment, cybersecurity, QMS software: topics of discussion, not a revision under way.

Validation of special processes under ISO 13485: sterilisation, welding, moulding

When a result can only be checked once the patient is exposed, final verification no longer suffices. Sections 7.5.6 and 7.5.7 of ISO 13485 then require upstream validation, typically structured into IQ, OQ and PQ.

Subcontractors and service providers: what are the real obligations under ISO 13485?

Section 4.1.5 requires outsourced processes to be controlled in proportion to risk, without requiring the provider to be certified. Regulatory responsibility stays with the manufacturer under Article 10 of the MDR.

ISO 13485 supplier qualification: requirements, method, pitfalls to avoid

A supplier's ISO 13485 certificate attests to its QMS, never to its ability to meet your specifications. Clause 7.4 requires control proportionate to risk and a documented periodic reassessment.

ISO 14971:2019: key changes compared with the 2007 edition (EN ISO 14971:2012)

Method and acceptability criteria for overall residual risk set in the plan, clinical benefits integrated into the benefit/risk analysis and post-production data: three substantive changes set the 2019 edition apart from the 2007 edition (EN ISO 14971:2012).

Hazard Identification under ISO 14971: Method, Sources and Completeness

Clauses 5.2 to 5.4 of ISO 14971:2019 structure hazard identification: intended use and reasonably foreseeable misuse, safety-related characteristics, then hazards and hazardous situations. Vigilance data usefully enrich it. The notified body checks not the completeness of the list but the systematic nature of the approach.

Risk control measures: hierarchy, effectiveness and verification

Inherently safe design outranks protection, which outranks information: the order of the three levels is not negotiable. Clause 7.2 demands objective proof of each measure's effectiveness, and 7.5 requires checking that no measure introduces new hazards or worsens existing risks.

The risk management plan: required content and structural mistakes

Section 4.4 of ISO 14971:2019 expects a document of method and governance, not a collection of results. Pouring hazards and assessments into it produces a hybrid that is hard to audit and to keep up to date.

Risk estimation and risk evaluation: acceptability criteria and the risk matrix

Under ISO 14971, a risk matrix only holds if its acceptability thresholds rest on data rather than a copied template. Notified bodies look above all for the same effect scored 3 on one line and 5 on another with no justification.

MDCG 2019-07 Rev.1 (December 2023): what the revision changes for the role of the PRRC and the authorised representative

December 2023: the MDCG revises its PRRC guidance after four years of MDR implementation. Combining the role with that of the EC REP authorised representative is explicitly ruled out, qualifications are clarified, and obligations are extended to importers who assume the manufacturer's responsibilities. What changes in practical terms for your regulatory organisation.

MDCG 2023-2024 guidelines: what really changes for medical device manufacturers

MDCG guidelines are not legally binding. They become operationally binding the moment a notified body applies them. Five 2023-2024 publications change what is expected in your MDR CE marking files.

MDR 2017/745: what really changed compared with Directive 93/42/EEC

The MDR did not revise the directive, it changed its logic: clinical evidence, continuous surveillance, end-to-end traceability. For directive certificates still in force, Article 120 set the final deadlines: end of 2027 and end of 2028.

MDR and AI Act: regulating medical devices that embed artificial intelligence

Medical devices that embed artificial intelligence now fall under two European regulatory frameworks at once: the MDR (EU) 2017/745 and the AI Act (EU) 2024/1689. Since the MDCG 2025-6 guidance was published in June 2025, the interplay between the two regulations has become clearer: classification under Article 6(1) of the AI Act, integrated conformity assessment through MDR notified bodies, and additional requirements for data governance, transparency and human oversight. With obligations postponed to 2 August 2028 (Regulation (EU) 2026/1744, in force since 27 July 2026), manufacturers gain extra time, not an exemption.

MDR technical documentation: the 6 sections of Annex II

Omitting a section does not make the file incomplete: it makes it non-compliant. Annex II structures the technical documentation into 6 sections, with sections 4 to 6 accounting for most of the exchanges with the notified body. The SSCP, the PMS plan and the PSUR fall under other provisions.

MDR Article 120: the transitional regime, what remains valid and until when

The validity of directive certificates is extended by operation of law (except those expired before 20 March 2023), but placing on the market until 2027 or 2028 is reserved for manufacturers that filed their application before 26 May 2024 and signed an agreement with a notified body before 26 September 2024, subject to five cumulative conditions.

MDR Distributor: New Obligations, Verifications and Traceability

Checking the CE marking, the language of the instructions and UDI registration conditions any making available. Traceability runs for at least 10 years, 15 for implantables, and co-branding shifts the distributor into manufacturer status.

Devices Manufactured and Used In-House by Health Institutions (Article 5.5 MDR)

Article 5(5) of the MDR allows health institutions to manufacture and use certain devices in-house, subject to strict cumulative conditions: a patient need not met by the market, an appropriate QMS, general safety and performance requirements, documentation, a public declaration and follow-up. Contrary to a widespread belief, no notified body intervenes systematically, whatever the class.

Demonstrating Clinical Equivalence under the MDR: Criteria, Limits and When It Is Genuinely Possible

Article 61.5 sets three cumulative criteria for equivalence, and citing a competitor's device requires contractual access to its data that almost no company grants. The route stays realistic only with a device from the same manufacturer.

Clinical evaluation under the MDR: what Article 61 actually requires

Article 61 turns clinical evaluation into a continuous process covering every class, class I included. For implantable and class III devices, the PMCF evaluation report and the SSCP are updated at least annually.

MDR Certificate Renewal: Plan Ahead to Avoid Losing CE Marking

The renewal audit covers the entire QMS and technical documentation like an initial audit: starting the process twelve to eighteen months before expiry is what secures continued CE marking.

MDR Classification: the 4 Risk Classes and the Logic of Annex VIII

Annex VIII of the MDR sorts medical devices into four risk classes through 22 rules, and when several apply to the same product, the one leading to the highest classification prevails.

MDR conformity assessment procedures: which route to choose by class?

Annex IX, X or XI: the chosen route sets the scope of the notified body's involvement and the length of the relationship. Annex IX, based on the QMS and the technical documentation, dominates lasting certifications by far.

European Commission decisions under the MDR: what SMEs must watch

The European Commission regularly issues delegated acts, implementing acts and common specifications that change the obligations of medical device manufacturers. Harmonised standards, clinical exemptions, MDR revision: these decisions often slip under the radar of SMEs, yet their impact on technical documentation and certification strategies is direct.

Reclassifying a Device Under the MDR: When to Anticipate and How to Manage the Transition

Leaving self-certification for a mandatory notified body means an investment of 60,000 to 120,000 euros and 18 to 24 months of work for a move from class I to class IIa. Most frequent cases: Rule 11 for software, the Ir sub-class for reusable instruments, Rule 8 for spinal implants.

The MDR Chain of Economic Operators: Who Is Responsible for What

Manufacturer, authorised representative, importer, distributor… Regulation (EU) 2017/745 shares responsibilities among several actors in order to secure the placing of medical devices on the market. Understanding each role is essential to avoid compliance mistakes.

12 min · Updated 15 September 2026 Read

The MDR Importer: regulatory obligations, responsibilities, traceability

Article 13 makes the importer a genuine regulatory checkpoint at the entrance to the European market, not a logistics provider: checks before placing on the market, identification on the packaging, traceability over ten to fifteen years, and reclassification as manufacturer if it sells under its own brand.

11 min · Updated 15 September 2026 Read

Medical device regulatory deadlines 2024-2029: the consolidated timeline for manufacturers

MDR, IVDR, AI Act, EUDAMED: between 2024 and 2029, medical device manufacturers face an unprecedented pile-up of regulatory deadlines. This article consolidates the dates, conditions and real timelines to build into your planning.

MDR Labelling: Mandatory Information, ISO Symbols and Language Requirements

Section 23 of Annex I sets every item to display, from the UDI code to the use-by date expressed unambiguously, at least as year and month (YYYY-MM format recommended). ISO 15223-1:2021 symbols avoid translation, but any text must appear in the language of each targeted Member State.

11 min · Updated 15 September 2026 Read

What is a medical device under the MDR? The borderline cases that trap manufacturers

MDR qualification rests first and foremost on the intended purpose claimed by the manufacturer, not on the form or technology of the product. Software, cosmetics, wellness products, Annex XVI aesthetic products and accessories are all borderline cases where a poorly controlled claim is enough to push a product into a more demanding regulatory framework.

MDR notified bodies: state of play mid-2026

52 bodies designated under the MDR in early 2026. That is better than in 2021, but file-review capacity remains a limiting factor. For a medical device manufacturer, the choice of notified body and anticipating timelines shape the entire certification roadmap.

Rule 11 of MDR Annex VIII: why so much software changed class

Class IIa for decision support and physiological monitoring, exceptions up to IIb and III, class I for all other software: Rule 11 changed the regulatory regime of most decision-support software. Since June 2025 the reference guidance has been revised, and earlier classifications need to be reread against the new text.

Updating the technical documentation: when should you review your MDR documentation?

A design change, post-market data or a new standard can make the documentation obsolete. It must always be kept up to date (Article 10(4)), and some changes must be reported to the notified body (Annex IX). MDCG 2020-3, often cited, only covers legacy devices.

MDR notified bodies: role, selection and real timelines 2026

52 bodies designated under the MDR in early 2026, timelines observed from 9 to 30 months depending on the class, and one variable the manufacturer controls entirely: the maturity of the file it submits. Selection method, designation codes, transfer conditions.

PMCF: post-market clinical follow-up — why so many plans fall short

The notified body first checks whether the clinical follow-up answers the CER's precise gaps, the leading reason for rejection. The programme spans the device's entire commercial life, not a two-year window.

PMCF Report (PMCFR) and Summary of Safety and Clinical Performance (SSCP)

One stays in the technical documentation, the other becomes public through EUDAMED under Article 32 of the MDR, mandatory only for implantable and class III devices. Two deliverables often taken one for the other.

PRRC and EC REP authorised representative: why combining the two roles is problematic according to MDCG 2019-07

The MDR does not explicitly prohibit one company from performing both functions. But MDCG 2019-07 Rev.1 rules out the non-EU manufacturer's PRRC and its authorised representative's PRRC being the same person and, for micro and small enterprises, belonging to the same external organisation: the authorised representative must provide an additional level of control.

Regulation (EU) 2023/607: extension of the MDR deadlines, who is affected and until when

Regulation (EU) 2023/607 amended Article 120 of the MDR to extend the certification deadlines according to the risk class. Certificate validity is extended by operation of law, but placing on the market is not unconditional: five cumulative conditions, intermediate deadlines that have already passed, and MDR obligations that apply right now. A breakdown article by article.

Systematic Literature Review for the CER: Method, Databases, Traceability

The systematic character separates a regulatorily acceptable review from a selection of favourable articles. Omitting unfavourable safety data breaches Annex XIV, Part A of the MDR, which requires both favourable and unfavourable data to be taken into account.

UDI: the Unique Device Identification system for medical devices

Four issuing entities, three identifiers, two separate timelines for the label and for EUDAMED. The part that really commits you is played out before the first code: in the grouping logic of the Basic UDI-DI.

12 min · 12 August 2026 Read

What an authorised representative really costs: price ranges, models and what to avoid

There is no official price list in Europe: some offers start at around €1,600 for the first year, others run to several thousand euros. The gap has less to do with the headline price than with what the mandate actually covers.

11 min · 11 August 2026 Read

How to choose your authorised representative: the criteria that non-EU manufacturers overlook

Beyond the annual fee, an EU authorised representative is judged on its ability to actually perform the tasks set by the MDR: keeping the required documents, cooperating with authorities, relaying sensitive requests, framing vigilance and maintaining a regulatory organisation separate from the manufacturer's.

12 min · 10 August 2026 Read

EC REP under MDR: obligations, responsibilities, and what the authorised representative can and cannot do

The authorised representative verifies, retains, checks and cooperates — it does not become the manufacturer in the manufacturer's place. Its joint liability is neither general nor automatic: it concerns defective devices, under the precise conditions of Article 11.

12 min · 9 August 2026 Read

EUDAMED Registration for Non-EU Manufacturers: the Role of the EC REP

Contrary to a widespread belief, the non-EU manufacturer registers in EUDAMED under its own identity and receives its own SRN. The authorised representative does not hold the account: it verifies the application, confirms the mandate and enables its forwarding to the competent authority.

9 min · 26 July 2026 Read

EUDAMED: what it is for and how to register

Provided for by the MDR and the IVDR, EUDAMED centralises the regulatory data of medical devices across six modules. Since 28 May 2026, four of them are mandatory. Everything starts with registration in the Actors module and obtaining the SRN, without which nothing else is accessible.

6 min · 10 June 2026 Read

MDR Vigilance: Who Reports What, and Within What Deadline

A serious incident must be reported within 2, 10 or 15 days depending on its severity. The clock starts when the incident becomes known, not when the causal link is confirmed: this is precisely where vigilance systems are caught out.

Software as a Medical Device (SaMD): technical documentation and specific requirements

A medical software falls under IEC 62304, which grades documentation across three safety classes from A to C, and under the cybersecurity framed by MDCG 2019-16. Its clinical data are algorithmic in nature.

8 min · 18 May 2026 Read

Building a realistic regulatory roadmap: milestones, resources, sequencing

The critical path of an MDR certification almost always runs through clinical data. Waiting for its completion to start the QMS adds 6 to 18 months to the schedule, while a 20 to 30 percent margin remains prudent.

8 min · 12 May 2026 Read

8 min · 25 April 2026 Read

End-of-life risk management review: when and how to conduct it

A serious incident, a novel complaint or a product change trigger an update of the risk management file: clause 10 of ISO 14971 requires tracing each review, which the notified body then checks at surveillance.

8 min · 19 April 2026 Read

The ISO 13485 management review: what it must really contain

Clauses 5.6.2 and 5.6.3 set out precise inputs and outputs. A review that records findings without deciding or allocating resources is non-compliant, and shows in five minutes of reading the minutes.

8 min · 2 April 2026 Read

Responding to a Notified Body Non-Conformity: Method and Expected Content

A response structured in five sections, from root cause to evidence of implementation, closes the finding; a thin response reopens it and can escalate a minor deviation into a major non-conformity.

8 min · 10 March 2026 Read

Rebuilding an MDR Technical Documentation File: Method and Priorities

Restoring compliance is won in the sequencing: classification, then risk management, clinical evaluation, drafting. Some steps stay incompressible, such as ISO 10993 biocompatibility, which takes three to six months.

8 min · 27 February 2026 Read

The MDR benefit-risk report: how to demonstrate that the benefits outweigh the risks

The most scrutinised section of the technical documentation collapses as soon as it settles for a claim without quantified evidence. Its conclusion must weigh quantified clinical gains against the dangers remaining after control, per ISO 14971.

8 min · 21 February 2026 Read

The real questions notified bodies ask during a technical documentation review

Technical, biological and clinical equivalence, PMCF proportionality to the gaps in the CER, management of significant changes: the same themes come back with every review, whatever the device.

7 min · 10 February 2026 Read

PRRC: the Person Responsible for Regulatory Compliance

Recruit or contract: Article 15 does not set the same requirement depending on the size of the manufacturer. Qualifications, tasks defined to the letter, outsourcing reserved for micro and small enterprises: the function appears on many organisation charts, less often in practice.

7 min · 6 February 2026 Read

FDA QMSR: ISO 13485 becomes a legal requirement in the United States

Since 2 February 2026, the FDA has incorporated ISO 13485:2016 into its positive law. Good news in principle for an EU manufacturer already certified. In the detail, several points call for a gap audit before any US move.

8 min · 1 January 2026 Read

Where to start when you discover the MDR with a product already on the market

The first instinct is often to rewrite existing procedures, when the priority is to verify the MDR classification against the 22 rules of Annex VIII. An unexpected rise in class costs several months of the programme.

8 min · 16 November 2025 Read

MEDDEV 2.7/1 rev 4: still applicable under MDR, and how?

Never formally withdrawn under the MDR, MEDDEV 2.7/1 rev 4 remains the most detailed clinical evaluation method, built in five stages. Notified bodies expect it to be complemented by MDCG guidelines 2020-5, 2020-6 and 2020-13.

8 min · 24 October 2025 Read

Class I CE Marking under MDR: Self-Certification, Yes — but Not Without a File

Self-certifying a class I device exempts the manufacturer from no technical documentation. The ANSM may request it at any time, and the clinical evaluation under Article 61 MDR applies with no class exception.

8 min · 19 October 2025 Read

Document management under ISO 13485: document control without bureaucratic overkill

Thirty procedures that are kept up and actually followed beat a catalogue of two hundred nobody opens. Clauses 4.2.4 and 4.2.5 separate documents from records, with a two-year retention floor that the MDR extends for technical documentation.

8 min · 13 October 2025 Read

Keeping an ISO 13485 QMS alive between two surveillance audits

Once the audit is over, the pressure eases and the QMS falls asleep: indicators abandoned, internal audits postponed, nonconformities left pending. Five routines, anchored in clauses 8.2.4, 8.5.2 and 5.6, keep the system alive instead of switching it back on three weeks before the auditor.

8 min · 26 September 2025 Read

The link between ISO 13485 and MDR: how the two frameworks fit together

An ISO 13485 certificate attests to a compliant quality system, not to devices compliant with the MDR. The clinical evaluation under Article 61, the technical documentation, UDI and EUDAMED all remain outside the scope of the standard.

8 min · 14 September 2025 Read

Preparing for an ANSM Inspection: Differences from a Certification Audit

The ANSM inspector holds powers a notified body auditor lacks: access to all premises, seizure of samples, hearings, and public health enforcement measures that can go as far as market withdrawal.

8 min · 5 August 2025 Read

In-House or Outsource? What SMEs Underestimate in Both Cases

A quality manager tied up for 18 months on an MDR project represents 60,000 to 90,000 euros invisible to the budget, while full outsourcing weakens internal ownership. The hybrid model most often remains the fitting choice for an SME.

8 min · 31 July 2025 Read

Clinical Evaluation of Medical Software (SaMD): Method and Acceptable Sources

Software produces information rather than a physical effect, so its clinical evidence rests on diagnostic performance and real impact on decisions. MDCG 2020-1 deems algorithmic performance alone insufficient.

8 min · 19 July 2025 Read

Clinical evaluation and risk management: how the two processes feed each other

Residual risks validated under ISO 14971 must be confirmed by the clinical data, and GSPR No. 1 of Annex I requires both processes to converge on a single, defensible benefit/risk conclusion.

Class IIa technical documentation: what the involvement of a notified body changes in practice

The notified body does not audit every reference: it assesses the QMS and a representative sample of the technical documentation. A first cycle takes 9 to 18 months, with a PSUR expected at least every two years.

8 min · 23 May 2025 Read

Clinical Data for Class I Devices: Clearing Up the Misunderstanding

Self-certification concerns the conformity procedure, never the clinical evaluation obligation: Article 61 covers every device. For class I, a documented literature review often suffices, provided it concludes on the GSPR.

8 min · 18 May 2025 Read

8 min · 8 April 2025 Read

How Much Does MDR Class IIa Compliance Really Cost

For an SME building on an existing base, MDR compliance for a class IIa device runs between 60,000 and 120,000 euros over 18 to 24 months, and climbs past 150,000 euros when starting from scratch.

8 min · 21 March 2025 Read

Choosing your notified body: selection mistakes and current timelines

Checking a notified body's designation in the NANDO database before any contact avoids the most common dead end: on timelines, a first file takes nine to fifteen months in class IIa and twelve to twenty-four months in class IIb.

8 min · 4 March 2025 Read

The documentation points that most often block Class IIb certification

Five areas of the file draw most of the requests for further information in class IIb, starting with a thin clinical evaluation: the equivalence route of Article 61.5 requires contractual access to data that is rarely available.

8 min · 10 February 2025 Read

The real timeline of an ISO 13485 certification from scratch: month by month

It is not documentation output that derails the schedule, but the underestimated rollout phase, postponed internal audits and piled-up CAPAs. A QMS needs three to six months of running-in before a notified body deems it operational.

8 min · 4 February 2025 Read

Managing a surveillance audit without getting caught off guard

The golden rule is brief: nothing specific before the notified body arrives. It checks that conformity holds continuously, with an up-to-date CER and changes assessed under MDCG 2020-3 guidance, not a last-minute sprint.

8 min · 6 January 2025 Read

ANSM and post-MDR market surveillance: first actions and signals

Self-certified Class I devices, non-compliant labelling, missed vigilance deadlines: the ANSM's first campaigns under the MDR target these three fronts. Its checks are proactive and do not depend on a previously reported incident.