The International Medical Device Regulators Forum (IMDRF) has published guidance document WG/N66FINAL:2021, titled ‘Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews’. The document explains the assessment process and outcomes, including the method to “grade and manage” nonconformities resulting from a recognizing Regulatory Authority’s assessment of a…
MDCG 2021-19, ‘Guidance note integration of the UDI within an organisation’s quality management system’, has now been published by the Medical Device Coordination Group (MDCG), detailing its advice on how, when implementing the requirements of the MDR/IVDR related to its QMS, manufacturers should consider how the UDI system and related MDR/IVDR obligations should be integrated….
The US Food and Drug Administration (FDA) has now finalized its guidance on requirements for unique device identifiers (UDI), nearly five years after releasing its draft guidance and eight years after issuing the UDI final rule. FDA said the final guidance is intended to describe “the requirements for, and FDA’s recommendations regarding, the form and…
MedTech Europe – the European trade association for the medical technology industry including diagnostics, medical devices and digital health – has provided rapid feedback on the decision by the Council of the European Union, to endorse the text of the future Regulation on Health Technology Assessment (HTA). MedTech Europe comments that: “Our industry supports EU…
MDCG 2021-13 rev.1, ‘Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR’, has now been published by the Medical Device Coordination Group (MDCG), adding a further question to the document….
Swissmedic, the medtech competent authority in Switzerland, issued a statement on 26 May 2021, titled ‘Modification of the Medical Devices Ordinance (MedDO) in the context of pending agreements between Switzerland and the EU’, which read, in part: “On 19 May 2021, the Federal Council approved supplementary provisions to the implementing regulations on medical devices. These…
The US Food and Drug Administration (FDA) has published two new draft guidance documents for public comment before 26 July 2021. The first is titled ‘Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry and Food and Drug Administration Staff’, available from here. This draft explains that…
Unique Device Identification (UDI) requirements have been introduced under Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), which become applicable from 26 May 2021 and 26 May 2022 respectively. The UDI system enhances the identification of medical devices and makes it easier to trace them when…
The European Medicines Agency has updated its 2015 Question and Answer guidance document on the combination product consultation procedure to align its content with the requirements of the Medical Device Regulation (MDR, 2017/745). The document has the catchy title of ‘Questions & Answers on the consultation procedure to the European Medicines Agency by notified bodies…
Eurofins Expert Services Oy, located in Finland, has become the twentieth Notified Body (NB) to be designated under the EU Medical Device Regulation (MDR, 2017/745) according to the NANDO database. Eurofins is Notified Body number 0537 and remains designated under the Medical Device Directive (MDD, 93/42/EEC) and In Vitro Diagnostics Directive (IVDD, 98/79/EC). The European…
