News
FDA advises new fees for FY 2022
The US Food and Drug Administration has now published its revised user fees for its fiscal year (FY) 2022, which starts on 1 October 2021. Any submissions or applications arriving at the Agency on or after 1 October 2021 will need to have paid the new fees, which are:
EMA issues guidelines for combination products
The European Medicines Agency (EMA) has published a new guidance document, titled ‘Guideline on quality documentation for medicinal products when used with a medical device’, providing advice on the quality information that manufacturers of combination products should submit in marketing authorization applications (MAA) to the Agency. The guideline also incorporates the recent revision of the…
First standards harmonised under MDR/IVDR
In only a trickle rather than the desired flood, the first five standards to be harmonised under the MDR and IVDR have been published in the Official Journal of the European Communities (OJEC). Four of the standards are identified for both MDR and IVDR, covering sterilization, and one has been identified for medical devices only,…
IMDRF publishes guidance on Conformity Assessment Body Assessment Process
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 publishes guidance on integration of UDI and QMS
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….
FDA finalizes long-awaited UDI guidance
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now finalized its guidance on requirements for unique device identifiers (UDI), nearly five years after releasing its draft guidance and eight years after issuing the UDI final rule.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 “remains sceptical” of future HTA regulation
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 updates Q&A guidance on Eudamed registration of non-economic operator actors
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 issues statement on becoming a ‘third country’
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…
Post-market issues covered by two new draft guidelines from FDA
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…
