Question 1

What are the MDR 2017/745 transition deadlines?

Accepted Answer

MDR 2017/745 transition deadlines differ by device risk class: Class IIb and III devices (high-risk) must comply by 31 December 2027; Class IIa and Class I (sterile/measuring) devices by 31 December 2028. Class III custom-made implantables had a deadline of 26 May 2026. These dates were established by Regulation (EU) 2023/607.

Question 2

How much time do MDD-certified devices have to transition to MDR?

Accepted Answer

Devices with valid MDD/AIMDD certificates must transition to MDR compliance by 31 December 2027 (high-risk) or 31 December 2028 (medium/lower-risk), depending on their risk class. It is recommended to approach a Notified Body no later than 2025-2026, as NB waiting times are increasing.

Question 3

What is a PMCF plan and what should it contain?

Accepted Answer

A PMCF (Post-Market Clinical Follow-Up) plan is a document prepared under MDR Annex XIV Part B to monitor the clinical performance and safety of a marketed device. Mandatory contents include: general and specific PMCF methods, justification of the methods, reference to the PMCF evaluation report, data collection timeline, and applicable standards. MDCG 2020-7 guidance should be followed.

Question 4

Is clinical evaluation mandatory for all device classes under MDR?

Accepted Answer

Yes, under MDR Article 61(1), clinical evaluation is mandatory for all risk classes of medical devices. For Class I devices, existing clinical data and literature review may be sufficient, while Class III and implantable devices require comprehensive clinical evidence and PMCF studies.

Question 5

How should Design Inputs, Verification, and Change Management be linked?

Accepted Answer

Any change made in product design means that the "design inputs" have changed. When a design input changes, the "design outputs", "design verification", and "design validations" linked to those inputs must be reviewed and repeated if necessary.

Question 6

What should be considered during the design process to facilitate certification?

Accepted Answer

The following steps must be carefully applied under the EN ISO 13485:2016 standard: 1. Design Planning: Forming the project team and preparing the design plan. 2. Design Inputs: Creating detailed and understandable inputs. 3. Design Outputs: Creating outputs that meet input requirements. 4. Design Review: Systematic evaluation. 5. Design Verification: Verification activities. 6. Design Validation: Checking conformity to user needs. 7. Design Transfer: Decision to transition to serial production. 8. Design Changes: Revision management.

Question 7

How should the number of samples for Design Verification be determined?

Accepted Answer

If a sample size is not specified in the test's own standard, the number of samples to be used must be statistically meaningful.

Question 8

Should Design Verification be performed on the finished product?

Accepted Answer

Design verification is the process of verifying inputs against outputs. If we are verifying inputs and outputs for a part of the product, the test can be applied to that part only. However, if the test result affects the functional operation of the entire product, it must be applied to the finished product.

Question 9

What does determining the worst case mean? How is a representative product selected?

Accepted Answer

The worst-case sample is the product that will represent the entire product family and cover all the most challenging characteristics. The aim is to show that by testing the worst-case sample with relevant tests, the result covers the other products in the product group. It should be remembered that the "worst case" may change for each test group, and there may be more than one "worst case" sample for a test.

Question 10

Should I use accredited laboratories? What can I do if the laboratory is not accredited?

Accepted Answer

There is an obligation to demonstrate the accuracy and validity of the test. If you are not working with an accredited laboratory, you must be familiar with the test method. You should audit the laboratory on topics such as how the test is conducted, reported, and the suitability of the laboratory environment, and retain the relevant records.

Question 11

Can I perform the tests myself?

Accepted Answer

Yes, if you have a suitable test environment and can validate your test method.

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