The 7 steps medical device manufacturers have to take to fulfill the requirements of EU-MDR (medical medical device regulation) and to obtain the CE mark. The quick start guide.

1. Conformityassessmentprocedure
7stepstotheCEmark
A crash course for (future) medical device manufacturers

2. Step1:Qualifyingthedevice
Document the intended purpose of the device
§ Medical purpose of the medical device
§ Intended patients, diagnoses, body parts
§ Physical principle of the medical deviceIntended users and use
environments
§ ...
Use the intended purpose to fix whether the device is a medical device.

3. Step2:Identifyingthelegalbasis
Determine which of the following EU regulations apply to your
medical device:
§ Medical Device Regulation MDR
§ In-vitro diagnostics regulation IVDR
Read the definitions in the MDR.

4. Step3:Determiningregulatoryrequirements
§ Determine the class of the device
– The MDR distinguishes between classes I, IIa, IIb and III
– The IVDR distinguishes between classes A to D
– Annex VIII of the MDR and IVDR determine the classification rules.
§ Determine conformity assessment procedures (see next
page)Determine basic safety and performance requirements
If you are unsure, ask your notified bodies or us:https://www.johner-institute.com/contact-us/

5. Annex II
Technical Documentation
Annex X
Conformity Assessment
by Type Examination
Annex IX
Conformity Ass. based on
QM System and Assessment of
Technical Documentation
Annex XI (Part A):
Conf. Ass. by Product
Conformity Verification:
Production QS
Annex IV and V
DoC to MDR
CE marking without NB
Annex IV and V
DoC to MDR
CE marking with NB
I IIb, III I*, IIa, IIb, III
I*, IIa
IIa
Specific
Assessment
Procedure
including
expert
panels
Annex XI (Part B):
Conf. Ass. by Product
Conformity Verification:
Product Verification (done by NB)
III*, IIb*
IIb, III
IIb, III
I*, IIa
DoC: Declaration of Conformität (Konformitätserklärung)
NB: Notified Body (benannte Stelle z.B. TÜV)
Class

6. Note
§ You always need a quality management system.
§ In the case of a conformity assessment procedure in
accordance with Annex IX (previous page, far right), that
quality management system must be certified.

7. Step4:EstablishingtheQMsystem
§ Establish an ISO 13485-compliant QM system. This will take
you a few months.
§ This investment will save you months of time and produce
better devices.
§ If you don't know how to establish a QM system, ask us:
https://www.johner-institute.com/contact-us/

8. Step5:Developinganddocumentingthedevice
§ Develop the device in accordance with your own QM system.
§ In this way, legally compliant technical documentation is created.
This contains, for example
– Intended purpose (see step 1) and instructions for use
– Risk management files
– Usability file
– Clinical evaluation

9. Step6:Declaringconformity/approvingthedevice
§ Create a declaration of conformity
§ Involve a notified body, except for Class I
§ Affix the CE mark to your device
§ Sell your device, help patients and earn
money!J

10. Step7:Monitoringthedeviceonthemarket
§ Create a plan (post-market surveillance plan)
§ Collect and evaluate information according to the plan
§ If necessary, define and implement measures (e.g., improve
device, improve processes, recall product, inform authorities)
§ Document activities (e.g., post-market surveillance report)

11. Wouldyoulikesupport?
Benefit from the fast and competent help of the Johner Institute so
that you can bring your devices to market quickly and with safety.
Get in touch with us:
§ https://www.johner-institute.com/contact-us/
§ info@johner-institut.de
§ +49 (7531) 94500 20