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CE Marking & Technical Documentation
CE marking and MDR technical documentation: building the file, conformity assessment routes, IFU, labelling and notified body readiness.
15 articles
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.
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.
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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