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New MDCG Guidances Published on PRRC and Implant Cards

8 July 2019

The Medical Device Coordination Group (MDCG) is working to develop guidance to ensure clarity and harmonized implementation of the new medical device regulations (MDR and IVDR). They are rapidly developing guidance documents: eight were produced until now! These guidances are intended to assist the European Commission and the Member States in implementing the MDR, but they are also very important for manufacturers and economic operators to understand what are the expectations and how to manage specific tasks related to the new Regulation.

Implant card, all you need to know 

The new implant card guidance MDCG 2019-8, provides information on the format, size and content of an implant card required under the MDR. It describes the intended use, content and information to be provided by the manufacturer together with the implant card and defines fields to be completed by the implanting healthcare institutions or healthcare providers. This guidance introduces symbols to be used on the implant card and recommends an instruction leaflet to accompany the card. Several examples have been included in the document.

Compliance Representative, all duties disclosed

The new guidance MDCG 2019-7 regarding the person responsible for regulatory compliance (PRCC) explains the qualifications, role and impact of the PRRC, including how to manage the outsourcing of this duty and the options applicable to small companies.

 

WHERE TO FIND ALL MDCG GUIDANCE DOCUMENTS

https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en

https://ec.europa.eu/docsroom/documents/36167

https://ec.europa.eu/docsroom/documents/36166

 

Questions? Contact us at  intouch@meditrial.net

 

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