Search results with tag "Mdcg"
Notified Body Position Paper
www.team-nb.orgWe can notice lack of MDCG Guidance’s, ommon specifications, Harmonised standards and Implementing acts under Regulations Proposed solution N s should be entitled to establish “good practices” for a harmonised approach. These documents could be prepared endorsed at the Team-NB level as the 1st step.
Ongoing Guidance development in MDCG Subgroups …
ec.europa.euBatch verification on class D IVDs . IVD . Q4 2021 ; 2. Standards . N/A . 3. Clinical Investigations and Evaluation (CIE) MDR . Clinical Investigation Report Summary Template . 2021 . 1. Stakeholders are not part of this group as it covers requirements set out by designating authorities specifically for notified bodies; stakeholders are ...
EU health preparedness: A common list of COVID-19 rapid ...
public.traveldoc.aeroDiagnostics Working Group of the Medical Device Coordination Group (MDCG IVD WG) regarding guidance on the performance of COVID-19 tests in the context of CE-marking and common specifications under Article 9 of Regulation (EU) 2017/7469. .
MDCG 2020-2 rev. 1 - European Commission
ec.europa.euMDCG 2020-2 rev. 1 Class I Transitional provisions under Article 120 (3 and 4) – (MDR) March 2020 July 2020 rev.1 This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member
MDCG 2021-5 Guidance on standardisation for medical devices
ec.europa.euMedical Devices Medical Device Coordination Group Document MDCG 2021-5 1 MDCG 2021-5 Guidance on standardisation for medical devices April 2021 This document has been endorsed by the Medical Device Coordination Group ... Directive 93/42/EEC on medical devices4 (MDD), applicable from 1 January 1995 until
MDCG 2021-6 Regulation (EU) 2017/745 – Questions & …
ec.europa.euRegulation (EU) 2017/745 – Questions & Answers regarding clinical investigation April 2021 . This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the
MDCG 2018-1 Rev.4 Guidance on BASIC UDI-DI and …
ec.europa.euMDCG 2018-1 Rev.4 . 3. Maximum number of Reuses . Annex VI Part B, 17 states that the manufacturer shall provide to the UDI database the maximum number of reuses of the device concerned, if applicable. ‘If applicable’ should be understood to …
MDCG 2019-16 - European Commission
ec.europa.euMedical Device Coordination Group Document MDCG 2019-16 rev. 1 Page 4 of 46 1. Introduction 1.1. Background The two new Regulations on medical devices 745/2017 (MDR) and 746/2017 (IVDR) (hereafter called the Medical Devices Regulations) have been adopted and entered into force on 25 May 2017.
MDCG 2020-13
ec.europa.eustandardised 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 procedure6 and reviews by designating authorities.7 Scope
MDCG 2021-3 Questions and Answers on Custom-Made …
ec.europa.eumedical devices (as defined by IMDRF ) are not qualified as CMDs and must follow the ‘standard’ MDR regulatory pathway for placing on the market. Examples of patient-matched devices: • Plates used to fix a broken bone, which are made by 3D printing, based on a template model and DICOM files/ images of the patient.
MDCG 2018-3 Rev - European Commission
ec.europa.eutrays for replenishment and sterilization for the request and for convenience of the healthcare provider and the healthcare system. Under the conditions set in Article 22(4), systems and procedure packs are to be treated as devices in their own right and the related natural or legal persons shall assume the obligations incumbent on manufacturers.
MDCG 2021-08
ec.europa.euThese documents are intended to be facilitative and their use by the Competent Authorities and sponsors is encouraged, however it is important to check with the individual Member State in which the clinical investigation is