Science Driven CRO

Science Driven CRO


Finding the art in medical device compliance

Notified Bodies need to evaluate the medical device´s operating risk-benefit ratio and various other factors and, in order for them to do so, the MDR 2017/745 and the MEDDEV 2.7.1 (Rev 4) states that they require a description of the “state of the art” in the medical field associated with the device.

In order to describe the state of the art, or the current knowledge about the device and its intended purpose, a literature search using broad terms and a recent timeframe is required.

Many sources of information and databases should be used to locate information for a comprehensive assessment, including PubMed, EMBASE and the Cochrane Database of Systematic Reviews. In addition to searching biomedical publication databases, other useful places to look for relevant information can include Competent Authority websites and registries, health technology assessment reports, and any clinical practice and consensus guidelines that may be available.

The state of the art needs to include a full description of the specific medical indication the device is intended to treat, the clinical background, and patient population. Alternative medical, surgical or other forms of treatments, along with their risks and benefits, including the “gold standard” treatment should also be described.

Data for any benchmark devices in the field should also be presented, focusing on the devices´ critical components. If there are any knowledge gaps that have been identified, these should be stated.

Once the source documents have been located and the information has been critically assimilated into a review of what is currently known about the field, then the subject device can be compared with each of the identified treatments and competitor products.

With an examination and analysis at this level of detail, it will be possible for both the authors and the Notified Body to evaluate and establish the baseline of risks and benefits from the perspective of the medical device and to establish where the medical device belongs within the state of the art.

Further Reading

Cochrane Database of Systematic Reviews
Click to read [Online] (Accessed: 14 OCT 2019)

Click to access [Online] (Accessed: 14 OCT 2019)

Medical Device Regulation:
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance.) 
Click to read [Online] (Accessed: 14 OCT 2019)

MEDDEV 2.7/1 revision 4:
European Commission. Clinical Evaluation: Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC. 
Click to read [PDF] (Accessed: 14 OCT 2019)

Click to access [Online] (Accessed: 14 OCT 2019)

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Neil Goodman

Neil Goodman, PhD, BSc(Hons) 
Senior Medical Writer

T: +32 9331 6030
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