Certification according to MDR

What does a Notified Body (MDR) do?

Notified bodies, such as Berlin Cert, are government-authorized bodies. They examine, evaluate and certify whether the required documents and the quality management system (QM system) comply with the uniform assessment standards of the Medical Device Regulation. Manufacturers require this certification as part of the conformity assessment to be carried out.

How long does an MDR procedure take?

No general statement can be made in this regard. According to experience, the procedure takes at least 9-18 months. The duration is significantly influenced by the completeness and quality of your documents.

Therefore, please ensure that all documents are complete at the time of application. We will inform you which documents these are when you make your request.

MDR certification procedure

On the basis of the short questionnaire completed by you and the product attachments, we check whether your request fits our scopes. In case of feasibility, we will provide you with a transparent offer.

To prepare a quotation, we need the fully completed short questionnaire and product appendices! For clarification of questions regarding the necessary information we offer online sessions.

Duration: typically 1-2 months

With the acceptance of the cost offer for the MDR, an application is created. After receipt of the application fee, the completeness of the documents will be checked within four weeks and the MDR certification will be scheduled.

Please ensure that all documents are complete at the time of application. Rejections or revocations of applications are transmitted to EUDAMED and can be viewed by other Notified Bodies.

Duration: typically 1-1.5 months

The clinical evaluation and technical documentation reviews take place in parallel. Depending on the number and quality of the documents, this step usually takes 3 to 12 months.

Duration: typically 3-12 months

After successful completion of the documentation audit, the QM documentation is audited, followed by an on-site audit (Audits stage 1 and 2). We schedule at least one month between the two stages to resolve non-conformities.

Duration: typically approx. 5 months

Upon completion of the on-site audit, you have 60 days to submit evidence of identified non-conformities, including root cause analysis. The auditor evaluates these within 30 days.

Duration: up to 3 months

As soon as all non-conformities have been marked as "resolved" by the auditor and the documentation check has been successfully completed, the procedure is handed over to a certification committee. Based on the previous results, this committee checks whether all requirements of the conformity assessment procedure have been met. If the result is positive, you will receive the certificates / attestations.

Duration: approx. 1 month

Within the MDR certification period, all outstanding technical documentation is reviewed and an unannounced audit is performed. Surveillance audits are performed for the QM system according to DIN EN ISO 13485, followed by recertification after three years.

MDR scopes of Berlin Cert

Berlin Cert GmbH offers certifications according to EU Regulation 2017/745 (MDR) respectively for Annexes IX, X, XI(A), XI(B) for medical devices of classes Ir, Im, IIa, IIb and III in the following scopes:

  • Active non-implantable devices for imaging, monitoring and/or diagnostic purposes.
    • MDA 0202: active non-implantable devices for imaging procedures with non-ionizing radiation
    • MDA 0203: active non-implantable devices for monitoring vital physiological parameters
    • MDA 0204: other active non-implantable devices for monitoring and/or diagnosis

  • Active non-implantable therapeutic devices and general active non-implantable devices
    • MDA 0302: active non-implantable devices with non-ionizing radiation
    • MDA 0305: active non-implantable products for stimulation or inhibition
    • MDA 0306: active non-implantable devices for extracorporeal circuits, for the administration or removal of substances and for hemopheresis (Restriction: Excluding active devices intended to deliver and/or remove drugs, body fluids or other substances to and/or from the body, when this procedure poses a potential hazard, taking into account the nature of the substances concerned, the part of the body concerned and the mode of application (Rule 12 Annex VIII Regulation (EU) 2017/745))
    • MDA 0307: active non-implantable respiratory devices
    • MDA 0309: active non-implantable ophthalmic devices
    • MDA 0310: active non-implantable ear, nose and throat devices
    • MDA 0311: active non-implantable dental products
    • MDA 0312: other active non-implantable surgical products
    • MDA 0313: active non-implantable prostheses, rehabilitation products and patient positioning and transport products
    • MDA 0315: software
    • MDA 0316: medical gas supply equipment and parts thereof
    • MDA 0317: active non-implantable products for cleaning, disinfection and sterilization (restriction: only cleaning and disinfection)
    • MDA 0318: other active non-implantable products
  • Non-active non-implantable products
    • MDN 1205: non-active non-implantable devices for orthopedics and rehabilitation
    • MDN 1207: non-active non-implantable diagnostic devices
    • MDN 1208: non-active non-implantable instruments
    • MDN 1214: general non-active non-implantable devices and other non-active non-implantable devices used in health care.

We are also happy to offer you accredited combined certifications with other standards through our cooperation partner GUTcert in Berlin. We will gladly take over the coordination.