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Article 10 MDR: what obligations for the medical device manufacturer?
Article 10 places on the manufacturer an obligation of system, not a list of formalities: QMS, technical documentation, PMS, vigilance and EUDAMED data kept consistent across the entire life cycle. Documentation is retained for at least 10 years, 15 for implantable devices.
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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.
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The 10 Most Frequent Nonconformities in ISO 13485 Certification Audits
A CAPA without root cause analysis, an expired calibration or missing software validation surface in nearly every ISO 13485 audit. Ten recurring nonconformities that can be neutralised before the certification body arrives.
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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.
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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. Implantable and class III devices call for an update at least once a year.
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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 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.
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. Section 7.5.6 of ISO 13485 then requires upstream validation, structured into IQ, OQ and PQ.
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.
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.
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.
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.
Use-Related Risk Management: ISO 62366 and Its Articulation with ISO 14971
ISO 62366 identifies foreseeable use errors while ISO 14971 assesses and controls the resulting risks. A technical file that addresses usability through the generic FMEA alone remains incomplete.
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 can amount to fraud within the meaning of Article 61 of the MDR.
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.
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.
Revision of ISO 13485: What We Know About the Next Version
Closer alignment with the MDR, cybersecurity, QMS software validation: the likely directions of the future standard are emerging, yet changing your system before the FDIS is published remains premature.
Terminating an EC REP Mandate: Procedure, Timelines and Risks for the Manufacturer
Any gap without a valid authorised representative makes marketing in the EU illegal: contract the new EC REP before notifying termination to the outgoing one, whose notice period runs from thirty to ninety days.
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.
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.
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. But the extension is neither automatic nor unconditional: five cumulative conditions, intermediate deadlines that have already passed, and MDR obligations that apply right now. A breakdown article by article.
Rule 11 of MDR Annex VIII: why so much software changed class
Class IIa by default, two exceptions upward: 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.
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.
Reclassifying a Device Under the MDR: When to Anticipate and How to Manage the Transition
Moving from class I to class IIa shifts self-certification to a mandatory notified body: an investment of 60,000 to 120,000 euros and 18 to 24 months of work, driven by Rules 7, 11 or 22 of Annex VIII.
The MDR benefit-risk report: how to demonstrate that the benefits outweigh the risks
The most scrutinised section of the technical file 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.
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.
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.
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.
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.
PRRC and EC REP authorised representative: why combining the two roles is problematic according to MDCG 2019-07
Placing the authorised representative and the person responsible for regulatory compliance with a single provider creates a structural conflict of interest. MDCG 2019-07 Rev.1, issued in December 2023, rules out this combination for the same manufacturer.
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.
PMCF Report (PMCFR) and Summary of Safety and Clinical Performance (SSCP)
One stays in the technical file, 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.
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.
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.
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.
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.
MDR notified bodies: role, selection and real timelines 2026
Between 45 and 50 bodies designated under the MDR, 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.
MDR notified bodies: state of play mid-2026
Mid-2026, around fifty notified bodies are designated under the MDR. That is better than in 2021, but still far short of the 80 that operated under Directive 93/42/EEC. For a medical device manufacturer, the choice of notified body and anticipating timelines shape the entire certification roadmap.
The MDR Chain of Economic Operators: Who Is Responsible for What
Manufacturer, authorised representative, importer, distributor: each answers for distinct obligations set precisely by Regulation (EU) 2017/745. A distributor that resells a device under its own brand shifts to manufacturer status and takes on those duties.
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.
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.
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. MDCG 2020-3 guidance defines the significant change that triggers a formal revision, and even a notification to the notified body.
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 6.3 demands objective proof of each measure's effectiveness, and 6.4 forbids creating new risks.
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.
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 (Digital Omnibus agreement, May 2026), manufacturers gain extra time, not an exemption.
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.
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.
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.
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.
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.
ISO 14971:2019: key changes compared with the 2012 version
A now mandatory risk management policy, clinical benefits integrated into the benefit/risk analysis, overall residual risk and post-production data: four substantive changes set the 2019 edition apart from the previous one.
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.
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 file, UDI and EUDAMED all remain outside the scope of the standard.
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.
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.
The MDR Importer: regulatory obligations, responsibilities, traceability
Article 13 of the MDR requires the importer to check CE marking, the EC REP mandate and EUDAMED registration before any placing on the market, then to keep batch traceability for at least 5 years, 10 years for implantable devices.
Instructions for Use (IFU) under the MDR: requirements of Annex I, Section 23
Section 23.4 of Annex I to the MDR lists around twenty mandatory items, 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.
Hazard Identification under ISO 14971: Method, Sources and Completeness
Section 5.4 of ISO 14971:2019 requires crossing several sources to list hazards: intended use, foreseeable misuse, vigilance data. The notified body checks not the completeness of the list but the systematic nature of the approach.
Risk Management for Medical Software: IEC 62304 and ISO 14971 Together
IEC 62304 sorts software into three safety classes, from A for negligible harm to C for death or serious injury, while ISO 14971 covers the whole device: the notified body expects both approaches to be linked in the file.
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.
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.
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.
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. Implantable and class III devices call for an update at least once a year.
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.
EUDAMED Registration for Non-EU Manufacturers: the Role of the EC REP
The ACTOR module requires an address in the Union, forcing any foreign manufacturer to go through its authorised representative to obtain the SRN. That identifier remains permanent, even when the EC REP is replaced.
EUDAMED: state of the modules and the 2026 obligation timeline
Since 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.
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.
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 expiry date in unambiguous YYYY-MM format. ISO 15223-1:2021 symbols avoid translation, but any text must appear in the language of each targeted Member State.
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.
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.
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.
EC REP under MDR: obligations, responsibilities, and what the authorised representative can and cannot do
Article 11(3) makes the authorised representative jointly liable with the non-EU manufacturer: EUDAMED registration, vigilance, retention of the technical file for five to ten years. Reducing this role to a box on the label exposes both parties.
MDR Technical Documentation: the 16 elements required by Annex II
Omitting a section does not make the file incomplete: it makes it non-compliant. Annex II imposes 16 mandatory headings, and sections 4 to 7 concentrate most of the exchanges with the notified body.
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.
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.
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 5 years, 10 for implantables, and co-branding shifts the distributor into manufacturer status.
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 the MDR. In the ancillary configuration, the notified body consults the EMA or a national authority before any certificate.
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.
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.
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.
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.
What an authorised representative really costs: price ranges, models and what to avoid
Depending on the device class, an EC REP charges between 800 and 10,000 euros a year. Below that, an offer of 500 euros for a class IIb or III device cannot cover the real obligations of the role.
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.
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.
How to choose your authorised representative: the criteria that non-EU manufacturers overlook
Beyond the annual fee, an authorised representative is judged on its ability to answer the authorities within the two days of a serious threat and on its compliance with MDCG 2019-07, which bars combining the EC REP and PRRC roles.
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.
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.
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 continuously: yearly for implantable and class III devices, every two to three years for classes IIa and IIb.
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.
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 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.
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.
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.
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.
MDR Article 120: the transitional regime, what remains valid and until when
The extended regime renews no certificate automatically: it rewards 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.
Article 10 MDR: what obligations for the medical device manufacturer?
Article 10 places on the manufacturer an obligation of system, not a list of formalities: QMS, technical documentation, PMS, vigilance and EUDAMED data kept consistent across the entire life cycle. Documentation is retained for at least 10 years, 15 for implantable devices.
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.
Manufacturing documentation (Annex III MDR): content and articulation with Annex II
Where Annex II describes what the device is, Annex III documents how it is made: processes, in-process controls, sterilisation validation. A process changed without updating the file creates a nonconformity with Article 10(4) of the MDR.
MDR GSPR: what notified bodies really check in your technical documentation
Risk management, clinical evaluation, biocompatibility, cybersecurity, labelling: all the evidence in a technical documentation exists to demonstrate conformity with the GSPRs of Annex I. It is also the first thing notified bodies examine.
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.
The 10 Most Frequent Nonconformities in ISO 13485 Certification Audits
A CAPA without root cause analysis, an expired calibration or missing software validation surface in nearly every ISO 13485 audit. Ten recurring nonconformities that can be neutralised before the certification body arrives.
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