MDR Clinical Considerations

The Clinical Evaluation Plan and Clinical Evaluation Report should demonstrate compliance to which of the following General Safety and Performance Requirements (select all that apply).

• A. GSPR 1 (safety of the device)

• B. GSPR 3 (risk management system)

• C. GSPR 6 (lifetime of the device)

• D. GSPR 8 (clinical performance of the device)

The requirements under which a manufacturer may use clinical data related to an equivalent device are the same under MDD and MDR.

• True

• False

The requirements under which a manufacturer may use clinical data related to an equivalent device are the same under MDR and MEDDEV 2.7/1_rev4 Appendix A1.

• True

• False

EU MDR 2017/745 and MDCG 2020-5 requires that which of the following characteristics are considered when demonstrating equivalence to another device (select all that apply).

• Technical

• Environmental

• Biological

• Clinical

• Innovative

What is the requirement for biological equivalence under EU MDR?

• Uses the same materials or substances in contact with the same human tissues or body fluids for a similar kind and duration of contact and similar release characteristics of substances, including degradation products and leachables

• Uses the same materials or substances in contact with the same human tissues or body fluids. Exceptions for devices in contact with intact skin and minor components of devices; in these cases risk analysis results may allow the use of similar materials taking into account the role and nature of the similar material.

• Biological characteristics relate to biocompatibility of materials in contact with the same body fluids/tissues.

• None of the Above

For a device application under EU MDR, can one claim equivalence to a device certified under the MDD 93/42/EEC?

• Yes

• No

• It Depends

EU MDR 2017/745 states that clinical investigations should align with ISO 14155: Good clinical practice for clinical investigations of medical devices for human subjects.

• Of course!

  ISO 14155 is recognized by multiple geographies so it’s logical to include it in the MDR.

• That’s crazy!

  The EC didn’t even issue harmonized standards until 2021.

Which of the following are applicable if you are collecting clinical data as part of a Post-Market Clinical Follow-Up (PMCF) study?

(Select all that apply).

• Pre-defined success criteria

• Statistically valid sample size

• Defined study population

• Defined statistical methods

If your device is exempt from clinical data under Article 61(6)(b) [WET devices] or Article 61(10) [Exception for Clinical Data], you do not need to perform a Post-Market Clinical Follow-Up (PMCF) study.

• True

• False

When can a survey be an appropriate form of PMCF? (Select all that apply).

• The product is mature with adequate clinical data

• New safety risks identified during PMS which warrant further investigation

• Stable design with no significant changes

• No outstanding questions of safety and performance