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Clifford Chance advises BVMed on new compliance standard

The standard is based on the ‘applicable legal requirements’ regarding management due diligence obligations on the interpretation of these acts in case law and on national and international standards and benchmarks

Clifford Chance has advised the German Medical Technology Association (BVMed) on developing the ‘BVMed Compliance Standard’ for the MedTech sector.

It revealed the new standard outlines the key elements required for an adequate compliance setup and offerd companies practical tips and suggestions.

Organisational frameworks to prevent companies from breaching compliance regulations have become increasingly important in recent years and the case law shows that one of the key due diligence requirements incumbent on managers is to take adequate steps to control compliance risks. 

According to the firm, the BVMed compliance standard contains practical advice and checklists for establishing a compliance setup and tips for performing internal compliance system audits. 

The Compliance Standard is based on the applicable legal requirements regarding management due diligence obligations on the interpretation of these acts in case law and on national and international standards and benchmarks.

Peter Dieners, healthcare/compliance partner at Clifford Chance and the firm’s regional managing partner Germany, said: “The new BVMed Compliance Standard is an excellent example of how an industry association can help its members improve their corporate governance in Compliance. This also enables them to meet enhanced ESG requirements.”

Marc-Pierre Möll, CEO of BVMed, said: “This practical guide is the first compliance standard to be issued by a European medical devices association. 

“Alongside the applicable laws and the medical devices code, it forms the third key resource which MedTech companies can use to ensure that their cooperation with medical institutions meets all the applicable legal requirements.” 

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