- Bibliographic databases
- Journals and other non-bibliographic database sources
- Unpublished and ongoing studies
If you plan to sell your medical devices in Europe, you must produce and maintain a Clinical Evaluation Report (CER) that complies with MEDDEV 2.7.1 revision 4 and the MDD or MDR 2017/745. Your CER documents the result of the clinical evaluation of your device. Clinical evaluation involves the assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device.
Some indications from our experience:
- CENTRAL is considered to be the best single source of reports of trials for inclusion in CERs.
- The three bibliographic databases generally considered to be the most important sources to search for studies for inclusion in CERs are CENTRAL, MEDLINE and EMBASE.
- National, regional and subject-specific databases should be selected for searching according to the topic of the CERs.
- Conference abstracts and other grey literature can be an important source of studies for inclusion in CERs.
- Reference lists in other reviews, guidelines, included (and excluded) studies and other related articles should be searched for additional studies.
- Efforts should be made to identify unpublished studies.
- Ongoing trials should be identified and tracked for possible inclusion in CERs on completion/updating.
- Trials registers and trials results registers are an important source of ongoing and unpublished trials.
Contact us firstname.lastname@example.org for more information about how we can help you comply with MEDDEV 2.7/1 rev 4 and perform literature reviews.