How to Apply for CE Certification under the MDR Directive？

Determine the Definition of Medical Devices:

A medical device is any tool, instrument, apparatus, software, implant, reagent, material, or other article, used alone or in combination for specific medical purposes on humans, as defined by the manufacturer:

   - Diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease.

   - Diagnosis, monitoring, treatment, alleviation, or compensation for an injury or disability.

   - Investigation, replacement, or modification of the anatomy or of a physiological or pathological process.

   - Providing information through in vitro examination of specimens derived from the human body (including organs, blood, and donated tissues) (Comment: IVD).

   - Its effectiveness is not achieved by pharmacological, immunological, or metabolic means, although such means may play a supporting role (Comment: primarily achieved through physical means).

   - Devices for contraception control or support.

   - Devices specifically intended for cleaning, disinfecting, or sterilizing other devices as described in the first subparagraph of this section and point 4 of Article 1.

Scope of MDR Directive:

The MDR applies to:

   - Medical devices.

   - Devices with medical purposes that are not intended for medical use (Appendix XVI).

The MDR does not apply to:

   - Human blood or blood products, plasma, or cells, or devices that incorporate such products, plasma, or cells at the time of placing on the market (excluding medicinal products derived from human blood or plasma with an ancillary function to the device).

   - Tissues, cells, or derivatives of human or animal origin, or products containing or consisting of such materials (excluding devices made from non-viable substances).

   - Products containing or consisting of viable biological substances or organisms (including live microorganisms, bacteria, fungi, or viruses) to achieve or support the intended purpose.

Classification of MDR Medical Devices:

Products are classified into classes: Class I, IIa, IIb, and III, with Class I including general Class I and special Class I (Is, Im, Ir). Note: Class Ir is defined as surgical instruments used for cutting, drilling, sawing, scraping, coagulating, clipping, retracting, shearing, or similar processes, not connected to any active medical device, and intended by the manufacturer to be reused after appropriate processing, such as cleaning, disinfection, and sterilization.

MDR Conformity Assessment Path (Annex IX):

When placing their devices on the market or putting them into service, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements of this Regulation.

Preparation of Quality Management System Documentation:

Annex IX Chapter I requires manufacturers to establish a quality management system throughout the product lifecycle, including design, production, inspection, and post-market surveillance. Manufacturers must create CE technical documentation and apply to a notified body for assessment. The notified body will evaluate the quality management system and sample the CE technical documentation. Upon compliance, an EU Quality Management CE System certificate will be issued. The notified body must conduct annual supervisory audits and unscheduled inspections to maintain the certificate's validity.

SRN & Basic UDI-DI and doc compliance Declaration:

   - SRN (Single Registration Number) is a unique identifier for each economic operator in the EU medical device database (EUDAMED) and in relevant official documents and reports.

   - Basic UDI-DI is a unique code and product characteristic for devices with the same intended use, risk class, and basic design and manufacturing characteristics.

   - After obtaining CE certification, manufacturers must provide a DoC (Declaration of Conformity) according to Annex IV, including:

     1. Manufacturer's and EU authorized representative's names and addresses, and SRN.

     2. Device name, specifications, and model.

     3. Basic UDI-DI information.

     4. Conformity assessment regulation and assessment path.

     5. Statement of conformity to general specifications.

     6. Date, place, and legally binding signature of the conformity declaration.