IVDR (CE) Certification

The In Vitro Diagnostic Medical Devices Regulation (IVDR — (EU) 2017/746) governs diagnostic tests carried out on samples taken from the human body and the related devices. Its biggest difference from the former Directive 98/79/EC is that the classification logic has changed completely: a rule-based risk classification from A to D has replaced the list-based approach, and as a result the large majority of devices that previously self-declared now fall within notified-body scope.

• Manufacturers of diagnostic kits and reagents
• Manufacturers of analysers and laboratory instruments
• Manufacturers of calibrators and control materials
• Developers of self-testing and point-of-care testing (POCT) products
• The relevant units for tests manufactured in-house at a healthcare institution (in-house/LDT)

Mandatory for devices within scope. For Class A (non-sterile) devices, the manufacturer self-declares; a notified body is involved for Class A sterile, B, C and D devices. Class D also has additional steps such as EU reference laboratory involvement and batch verification.

• Scope, definitions and classification rules (Annex VIII, Rules 1-7)
• General safety and performance requirements (Annex I)
• Performance evaluation: scientific validity, analytical performance, clinical performance (Annex XIII)
• Risk management and the benefit-risk balance
• Technical documentation (Annex II) and post-market surveillance documentation (Annex III)
• Post-market performance follow-up (PMPF)
• The quality-management-system requirement and its relationship with ISO 13485
• UDI and EUDAMED registration obligations
• EU reference laboratory involvement and batch verification for Class D
• Requirements for devices manufactured within a healthcare institution (article 5(5))
• Vigilance and field safety corrective actions

1. 1Determining the LegislationIt is determined which EU legislation applies to the product. A product can fall within scope of more than one piece of legislation at the same time; all of them must be met.
2. 2Selecting the Conformity Assessment ModuleThe legislation determines the module to follow according to the product's risk class. The manufacturer self-declares under some modules, while a notified body is involved under others.
3. 3Testing Against Harmonised StandardsConformity with harmonised standards published in the EU Official Journal is demonstrated through testing; this provides a presumption of conformity with the legislation.
4. 4Risk Analysis and the Technical FileThe risk assessment, design calculations, test reports, instructions for use and sample labels are compiled in the technical file.
5. 5The EU Declaration of ConformityThe manufacturer or its EU-based authorised representative signs the declaration of conformity. Responsibility rests with the signatory of the declaration.
6. 6Affixing the CE MarkThe mark is affixed to the product in the form and size the legislation prescribes; the notified body's identification number is added if one is involved.
7. 7Retaining the Technical FileThe technical file is retained for the period the legislation sets from the product's placing on the market (10 years under most legislation) and presented to the competent authority on request.

The CE mark is not a certificate but the manufacturer's declaration of conformity, and it has no expiry. However, the declaration remains valid as long as the product and the legislation do not change: the technical file must be updated if the legislation or the harmonised standard is updated. Notified-body certificates (e.g. an EU Type-Examination Certificate) are subject to a validity period.

• The product description, model list and technical drawings
• Risk assessment
• The list of harmonised standards applied
• Test reports
• Instructions for use and warning labels (in the target market's language)
• A draft EU Declaration of Conformity
• The device description, intended purpose and classification rationale
• Analytical performance data: accuracy, precision, specificity, sensitivity, measuring range, interference studies
• Clinical performance and scientific-validity evidence
• Stability and shelf-life studies
• The risk management file
• The software file (IEC 62304, if applicable)
• The label, instructions for use and UDI information
• ISO 13485 quality-management-system documentation

There is no fixed list price; the cost is calculated based on the following variables and provided in writing in the quote.

• The number of pieces of legislation applicable to the product
• The conformity-assessment module — whether a notified body is involved
• The required test scope and number of samples
• The current state of the technical file
• Translation and documentation needs

A Notified Body under CE is registered in the European Commission's NANDO database for the relevant EU regulation and carries a four-digit identification number. Notified body authority is based on legislation and product scope; The authority granted for one regulation does not extend to another. Testing is within the scope of ISO/IEC 17025, product certification is within the scope of ISO/IEC 17065.

The scope under which this scheme can be offered varies according to your product and activity; it is confirmed in writing at the quote stage.

• CEMDR
• CEMachinery Safety
• CELVD
• CEEMC
• CERED
• CEPED
• CESPVD
• CEATEX