Essentials of European Medical Device Regulatory Affairs - June 2020

Clinical Evaluation : Article 61

Conformity to the general safety and performance requirements (AnnexI) is based on clinical data to show

AnnexI. (1). device performance, acceptable benefit/risk

AnnexI. (8). any foreseeable risks and minimisingundesirable side effects

Provide necessary labelling information required in AnnexIII.

The level of clinicalevidence required should be appropriate to the device and its intended performance.

a clinical evaluation is required for all devices (Follow Annex IV Part A and MEDDEV).

The requirement for a clinical evaluation report is not new.

(MDD Essential requirement 6a.)

TheOrganisation for Professionals in Regulatory Affairs

Clinical Evaluation

The clinicalevaluation report will contain • Scientific literature of equivalent devices • Results of clinical investigations– critical assessment • Device shouldbe discussed in the context of alternative treatments.(not just devices)

-----------------------------------------------------------------------------------

For Class IIIand Class IIbactive devices for administering/removingmedicines

the company can ask the clinical expertpanel for advice on the development strategy and about the planned clinical investigation.

The panel’s advice needs to be recorded in the CER.

There is no provision for gaining scientificadvice other classifications

80

Clinical Evaluation Clinical investigations(CI) areexpected for implantable and class III devices unless it is duly justified to rely on existing clinical dataMDD AnnexX directive 93/42/EEC MDR exceptions arenow…… -------------------------------------------------------------------------------------- if it is a modification of a device by the samemanufacturer. TheNBwill check thepostmarketing clinical follow up (PMCF) plan contains appropriatepost marketing studies to demonstratesafetyandperformanceof the device. --------------------------------------------------------------------------------------- Wheredatewas generatedunder theMDD and meetsa common specification ---------------------------------------------------------------------------------------- is on the list ofwell understoodproductse.g. dentalbraces. ---------------------------------------------------------------------------------------- If equivalent to anothermanufacturer’sMDR compliant device and contractallows access to the technical file. ----------------------------------------------------------------------------------------- Article61 (10) if clinicaldata isnotappropriate ----------------------------------------------------------------------------------------- And thatmodification createsan equivalent device to the first device and theNBagrees it is equivalentand the clinical evaluation of the original devicewould cover themodification.

Any justifications for not conductingaCI are included in theCER.

81

27