Albeit half of the deadlines for the endorsement of MDCG Guidance is not yet defined (TBD), however here below we present the documents that shall be published until the end of 2019:

Notified Bodies Oversight (NBO)

• Sampling of devices on a representative basis

• Explanatory note on codes

Standards

• Commission Implementing Decision (Standardisation request)

Clinical Investigations and Evaluation (CIE)

• Clinical investigation application

• Clinical investigation assessment template

• Processes and templates relative to CI and PS Assessments

• Template Post-Market Clinical Follow-up Plan

• Template Post-Market Clinical Follow-up Plan Update

• SAE reporting EUDAMED requirements – form

• Report form for Serious Adverse Events

• Process flow for SAE reporting

Market Surveillance (MS)

• Class I manufacturers

It is scheduled that there will be an update to the PRRC document provided in 2020.

New Technologies

• Clinical Evaluation of Software

Unique Device Identification (UDI)

• Integration of UDI in manufacturers’ QMS

• Guidelines on specific product types (contact lenses)

• Formats of AICD and HRI parts of UDI carriers

In vitro Diagnostic Medical Devices (IVD)

• Classification of IVDs

Nomenclature

• Information package on EMDN (for website)

• Rules and process for update of EMDN

• List of EMDN terms to be used for implant card purposes

 

---

Have a look at all published MDCG Guidance in our Library of Documents.

Follow our LinkedIn and Facebook page for all the recent documents from the MDCG!