MDR (CE) Certification

The Medical Device Regulation (MDR — (EU) 2017/745) governs the placing of medical devices on the EU market and has replaced the former Directive 93/42/EEC. The MDR is stricter: the clinical-evidence expectation has risen, post-market surveillance and clinical follow-up requirements have been strengthened, many products have moved to a higher risk class, and EUDAMED database registration together with the UDI (unique device identifier) system has been introduced for all devices.

• Medical device manufacturers and firms responsible for design
• Organisations placing a device on the market under their own brand
• EU-based authorised representatives, importers and distributors
• Developers whose software qualifies as a medical device (SaMD)
• Organisations assembling systems and procedure packs

Mandatory for medical devices within scope. Notified-body involvement depends on the risk class: for Class I devices (not sterile, without a measuring function, and not a reusable surgical instrument), the manufacturer self-declares; a notified body is involved for Class Is, Im, Ir, IIa, IIb and III devices. Assessment is most extensive for Class III and implantable devices.

• Scope, definitions and classification rules (Annex VIII)
• General safety and performance requirements (Annex I)
• Risk management (ISO 14971) and the benefit-risk balance
• The content of the technical documentation (Annex II) and post-market surveillance documentation (Annex III)
• Clinical evaluation, clinical investigation and equivalence evidence (Annex XIV)
• Post-market clinical follow-up (PMCF)
• The quality-management-system requirement and its relationship with ISO 13485
• The UDI system and EUDAMED registration obligations
• Conformity-assessment routes (Annexes IX, X, XI) and how they are chosen by risk class
• Vigilance: serious-incident reporting and field safety corrective actions
• Appointing a person responsible for regulatory compliance (PRRC)
• Obligations of the authorised representative, importer and distributor

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
• The general safety and performance requirements checklist
• Risk management file (ISO 14971)
• Biocompatibility (ISO 10993 series), sterilisation and packaging validation reports
• Electrical safety and EMC reports (the EN 60601 series, if applicable)
• The software lifecycle file (IEC 62304, if applicable)
• The usability engineering file (IEC 62366-1)
• The clinical evaluation report and the PMCF plan
• 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.

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