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haber S ğlık

manufacturer and the competent authorities when necessary. regarding the access to clinical documentation and full tech-
All economic operators are responsible for verifying the suita- nical documentation.
bility of their top supplier. Authorized representatives will be Clinical Research
responsible for products on the market as well as manufactu- Detailed requirements on clinical researches are defi ned in
rers. Manufacturers must take out a policy to compensate for MDR. While all clinical trials that will start before May 26,
possible negative situations. 2020 will be conducted according to the legislation in force, all
Further control over notifi ed bodies clinical trials to be carried out after this date should be based
Detailed requirements for notifi ed bodies are defi ned in MDR. on the detailed requirements in MDR.
(Section IV and Annex-VII) Notifi ed bodies will be audited by PMS and PMCF
more closely supervised and well-trained co-evaluation teams. Post-market surveillance (PMS) is defi ned as a separate
Especially in Class II-b active devices defi ned in Class III and annex (Annex-III) in MDR and should be prepared as part of
MDR, notifi ed bodies will report it to the expert panel over the the technical documentation and integrated with the quality
European Commission after evaluating the clinical evaluati- management system. Arrangements should be made to provide
on documentation. The scientifi c opinion of the panel consis- data that will be the most important input of the clinical docu-
ting of impartial experts will establish a basis for certifi cation. mentation that will be constantly updated. Post-market clinical
Clinical Evaluation follow-up (PMCF), on the other hand, is of special importan-
It is essential that the documentation required for clini- ce since the clinical evaluation documentation will be upda-
cal evaluation include clinical data that is generated from the ted with data directly related to the device. PMCF plan and
use of the medical device being investigated. This is actually content are described in detail in MDR (Annex-XIV Part B).
more important than the literature review of clinical trials and PMCF plan, including each device, should be aimed at verif-
investigations submitted for an equivalent medical device in ying safety and performance, side effects, risks and the like
accordance with the provisions of the MDR. Clinical data that and should be prepared to include the methods and procedure
is constantly updated throughout the life of the device will be used together with the purpose and timeline.
the most important part of the clinical evaluation documen- Vigilance and Market Surveillance
tation. Arrangements for direct clinical data of the device, in Reporting of vigilance and market surveillance activities
case it is applicable with MDR, should be made by the manu- will be done through EUDAMED. The relevant data will be
facturer. Detailed requirements for equivalent device selection accessible to the European Commission, competent authori-
and display are defi ned. Clinical research obligation has been ties, notifi ed bodies but will be partly accessible to the public.
imposed for all implantable and all Class III devices except for Non-serious events should be reported with trend reporting.
those excluded in MDR. Clinical research obligation may not (side effects etc.) Manufacturers should constantly evaluate
be applied to products that have been previously presented to the compliance of the devices they manufacture in accordan-
the market under the medical device regulation and that have ce with the general safety and performance requirements. The
adequate clinical data together with devices manufactured and suitability of the devices involved in the incidents and / or cor-
modifi ed by the same manufacturer. Likewise, the manufac- rective actions will be continuously followed-up by the com-
turer may not conduct clinical research based on the equiva- petent authority.
lent device, but in this case there should be a contract betwe- Benefi t-Risk analysis and its importance, PMS report and
en the manufacturer and the equivalent device manufacturer PSUR

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