Update: EC Implementing acts and MDCG Guidance in 2020 & 2021

With the release of the latest Implementation Rolling Plan, we present below future implementing acts/actions by the European Commission and respective dates of publication:

Q1 2021

  • Standardisation Request
    • After the rejection by CEN/CENELEC of the act adopted by the Commission in June 2020, a new draft of the Commission Implementing Decision for the MDR/IVDR Standardisation Request is under development, to be submitted to the opinion of the Committee on Standards, then to be adopted by the Commission and addressed to CEN/CENELEC for their acceptance
  • Rules to facilitate fulfilment of tasks by EU reference laboratories and to ensure their compliance with criteria
  • Fees for EURL services
  • EUDAMED: Definition of detailed arrangements necessary for the setting up and maintenance of Eudamed
  • EUDAMED UDI Helpdesk

Q2 2021

  • Common Specifications for Annex XVI (products without a medical purpose)
  • Common specifications for IVD Class D

Q3-Q4 2021

  • Setting up of new structures under IVDR:- EU reference laboratories


  • EUDAMED go-live
  • EUDAMED: Audit of functional specifications

The MDCG also published the Ongoing guidance development within MDCG Subgroups- December 2020. An extract of future MDCG endorsed guidance documents with the planned date of MDCG endorsement:


  • 1st release of EMDN

Q1 2021:

  • IVDR Explanatory note on codes
  • Batch verification on class D IVDs
  • Rules for allocation of EMDN to UDI-DI


  • MDR Classification of medical devices
  • MDR Guidance on clinical evaluation consultation procedure
  • Guidance on Certifications according to Article 16 MDR/IVDR)
  • Guidance on appropriate surveillance according to Article 120(3)
  • Borderline with medicinal products (including general guidance, definitions of pharmacological, immunological and metabolic means of action anddiagnosis)
  • MDR Q&A on Custom-Made & Adaptable Devices
  • Legal status of app providers
  • EUDAMED Guidance on harmonised administrative practices and alternative technical solutions
  • Update of PRRC Guidance
  • Authorised Representatives
  • Guidelines on Re-labelling & Re-packaging
  • UDI Guidelines on specific product types (contact lenses)
  • IVDR Performance evaluation
  • Transfer of Common Technical Specifications (IVDD) to Common Specifications (IVDR)
  • Vigilance requirements
    • Task Force has met 2 times. Work to last until Q2 2021


  • Post-market surveillance requirements
    • Task Force to complete the tasks under development by CIE and MS subgroups
  • Translation of EMDN
  • IVDR Development of common specifications
    • Draft CS almost finished for Kidd&Duffy, Chagas, syphilis, CMV and EBV
  • IVDR SSP (Summary of Safety & Performance)
  • IVDR Qualification of assays used in clinical trials of medicinal products

Overview of the MDCG guidance development can be found be here.


(all related documents available in our Library of documents – STANDARDS)

The European Commission released the annual Union work programme for European standardisation for 2021, where it states that the development of standards ”responding to the technological updates and the market demands for medical devices is crucial” in view of COVID-19 and to support the MDR & IVDR. The EC action is presented in the table below:

Regulation (EU) 2017/745 on Medical Devices and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices

Revision of existing standards and development of new standards for medical devices and in vitro diagnostic medical devices.

The main objective is to update the existing standards to the state of the art in sectorial technologies to enable users and patients to benefit from the highest level of safety.

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