23.12.2020
Newsletter
MDR/IVDR – what’s new?
As preparations continue for the application of the new medical devices Regulation (MDR) and in vitro diagnostic medical devices Regulation (IVDR), we strive to keep you up to date on all relevant news and events. In this issue of our newsletter we highlight some of the guidance currently available to help you prepare for the new Regulations, particularly within the context of the COVID-19 pandemic and efforts to manage it and mitigate its impacts.
In this issue:
EUDAMED Actor module now available
Q&A address notified body audits during quarantine orders and travel restrictions
State of Play for Joint Assessments
Clarity on UDI assignment for spectacle lenses & ready readers
Laying down common specifications rules for reprocessing of single-use devices
Guidance on classification rules for in vitro diagnostic medical devices
Clinical evaluation assessment report template
EUDAMED Actor module now available
On 1 December 2020, the European Commission made the EUDAMED Actor registration module available to Member States and economic operators. This is the first of the six EUDAMED modules that will gradually be made available, as they become functional.
The Commission is not in a position to require the use of the Actor registration module until EUDAMED is fully functional according to the medical device Regulation (MDR), so additional national requirements on registrations cannot be ruled out.
For more information, click here.
Q&A address notified body audits during quarantine orders and travel restrictions
The Medical Device Coordination Group (MDCG) has published the MDCG 2020-17 guidance document. The document is a set of questions and answers on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions and is applicable under the medical devices Directives.
Aspects covered in the Q&A were identified during implementation of the guidance document “MDCG 2020-4 Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions”. The Q&A provide further details on the operational and practical implementation of the principles outlined in the guidance document and should be read along with the document.
To access the MDCG 2020-17 document, click here.
Commission issues notified bodies assessment state of play
The European Commission has issued a state of play of the joint assessment of notified bodies in the medical devices field. Updated on 11 December 2020, the state of play provides as overview of notified bodies at each stage of the designation process, along with the number of notified bodies to apply for designated status, and other information.
To view the state of play, click here. For a continuously updated list of the designated notified bodies, check the NANDO Information System. For more information, click here.
Clarity on UDI assignment for spectacle lenses & ready readers
The Medical Device Coordination Group (MDCG) has published the MDCG 2020-18 document. The document is a position paper on UDI assignment for spectacle lenses and ready readers. The document aims to provide clarification on UDI assignment obligations for manufacturers of spectacle lenses and ready readers. It should be read in conjunction with the relevant provisions of Regulations (EU) 2017/745 and related UDI guidance documents.
To access the MDCG 2020-18 position paper, click here.
Laying down common specifications rules for reprocessing of single-use devices
In August 2020 the OJEU published the Commission Implementing Regulation (EU) 2020/1207 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards common specifications for the reprocessing of single-use devices
To read Regulation (EU) 2020/1207, click here.
Guidance on classification rules for in vitro diagnostic medical devices
The Medical Device Coordination Group (MDCG) has published the MDCG 2020-16 document. The document is a Guidance on Classification Rules for in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746. The document addresses the classification of IVDs and provides clarifications on the classification rules as set out under Annex VIII. This classification guidance also applies to diagnostic or information society services performed on EU patients, or devices put in to service through distance sales.
The primary purpose of this document is to provide guidance to manufacturers, notified bodies and health institutions on how to classify an IVD prior to placing it on the market, making it available on the market or putting it into service in the EU. It also aims to inform regulators and other stakeholders when assessing the class attributed to an IVD by a manufacturer or a health institution.
To access the MDCG 2020-16, click here.
Clinical evaluation assessment report template
A clinical evaluation assessment report (CEAR) is a report used by a notified body to clearly document the conclusions of its assessment of the clinical evidence presented by the manufacturer in the clinical evaluation report (CER) and the related clinical evaluation that was conducted – a core requirement of the Medical Device Regulation.
The Medical Device Coordination Group (MDCG) has published the MDCG 2020-13; the document contains a harmonised CEAR template to provide a standardised method for documenting the notified body’s assessment of the manufacturer’s clinical evaluation and related documents. CEARs in this format will also support specific additional requirements such as the clinical evaluation consultation procedure and reviews by designating authorities.
To see the template, click here.
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