Strategies and Services for Medical Devices
The Medical Device Regulation (MDR) has tightened the regulatory requirements for many established and safe products. Together with you we will find the right strategy for conformity assessment.
We support you in assessing for which medical devices of classes I-III in your portfolio the changeover is worthwhile and whether the effort can be reduced, for example, through permissible literature references. For borderline products, we advise on questions of demarcation and identify attractive alternatives, but also suitable portfolio additions for our customers.
Market access & product maintenance with responsibility
The success and safety of your medical devices are in the best hands with TentaConsult. We create and maintain the necessary documents, documentation and QM systems. In short: We support you in all tasks and decisions up to market access – and also take personal responsibility beyond that.
Assumption of responsibility as Authorised Representative (EC-REP according to Article 11 MDR)
A medical device manufacturer established outside the EU must appoint an Authorised Representative (EC-REP) established in the EU to fulfil the requirements for placing medical devices on the EU market in accordance with the MDR (Article 11).
For these manufacturers, the authorised representative plays a central role as their contact person established in the Union. In case of requests from EU authorities, this authorised representative is contacted and has to ensure that the requests and all required information are provided and handled correctly.
TentaConsult assumes the role of authorised representative and competently handles all related activities and formalities on behalf and in the interest of the manufacturer.
Clinical evaluations up to risk analysis
A central aspect of the technical documentation for the conformity assessment procedure is the Clinical Evaluation, for which we prepare, for example, the Clinical Evaluation Plan (CEP) and Clinical Evaluation Reports (CER). With literature-based Clinical Evaluations, we efficiently fulfil the requirements of the Notified Bodies and, if necessary, advise on the design of further studies.
On behalf we take responsibility:
- Conformity assessment procedure
- Classification and demarcation assessment
- Clinical Evaluation Report (CER)
- Risk management
- Biological Evaluation Plan (BEP) / Report (BER)
- Establishment of QM systems (ISO 13485)
- Tests for biocompatibility / biological safety
We take over responsible roles:
- Authorised representative (EC REP) (acc. to Article 11 MDR)
- Safety Officer (acc. to § 30 MPG)
- Person Responsible for Regulatory Compliance (PRRC) (acc.to Art. 15 MDR)
