News

08.08.16

MEDDEV 2.7/1 revision 4

MEDDEV 2.7/1 revision 4 – Clinical Evaluation – was published end of June without transition period and presents a new challenge for manufacturers of medical devices.

 

The current revision of the MEDDEV 2.7/1 places, amongst others, the following further requirements on the preparation the clinical evaluation:

  • The required extent of the clinical evaluation is to be analyzed in advance for the particular medical device and documented as clinical evaluation plan.
  • In the chapter entitled “state of the art,” all alternative therapies for the indications for which the medical device is intended to be used are to be identified and evaluated regarding their benefit/risk profile.
  • Published clinical data are to be appraised in more detail in terms of their contribution to and suitability for the clinical evaluation.
  • Compliance with the Essential Requirements of Annex I of Directive 93/42/EEC regarding performance, safety, side effects and benefit/risk profile is to be checked in detail.
  • At the end of the clinical evaluation, a gap analysis is to be carried out to identify unanswered questions and to define suitable PMCF measures
  • The duration of validity of the clinical evaluation is to be specified and justified. According to the MDR draft, this will be two to five years, respectively one year if the device carries significant risks or is not yet well established.
  • The required qualification of the authors has been defined more precisely and is to be documented in the clinical evaluation. Possible conflicts of interests shall be disclosed.

We have modified our processes accordingly and as of now conduct clinical evaluations pursuant to the revised MEDDEV 2.7/1.

If you have any questions related to these new regulations, please feel free to contact us!