Upcoming Regulation 2023/607 Transitional Provision Deadlines for MDR

On March 15, 2023, citing the impact of the COVID-19 pandemic, the lack of designated notified bodies and the associated over-capacities, and the imminent threat of significant shortages of necessary medical devices available on the market, the EU set forth Regulation 2023/607, amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for […]

MDR Compliance

 Challenge: A long-standing client, a small company specializing in innovative minimally invasive endosurgical devices, needed to maintain their existing CE Mark while updating their QMS to comply with the new Medical Device Regulation (MDR). Facing limited resources to implement the new regulations and update their documentation for an MDR submission, they trusted AlvaMed’s proven track […]

MDCG UPDATES Q&A ON IMPORTERS AND DISTRIBUTORS

The Medical Device Coordination Group (MDCG), the regulatory body that works toward ensuring the safe and effective use of medical devices in Europe, recently updated a Q&A document on how both the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) apply to importers and distributors. Under both regulations, an economic operator is defined […]

DO NOTIFIED BODIES HAVE THE CAPACITY TO MANAGE THE MDR AND IVDR TRANSITIONS?

While recent information shows that both Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) applications have been on the rise, there are concerns as to whether the Notified Bodies have the capacity and competency to accommodate this trend. In March of this year, the EU commission released Regulation (EU) 2023/607, with immediate effect.  […]

MANAGING CHANGES AND MAINTAINING COMPLIANCE

Under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), devices need to meet the applicable “harmonized standards” to demonstrate conformity with the essential requirements. If a harmonized standard referenced in the technical documentation (including the DHF) is updated, manufacturers are expected to assess the impact and incorporate any necessary changes […]

GUIDANCE ON SIGNIFICANT CHANGES REGARDING THE TRANSITIONAL PROVISION UNDER ARTICLE 120 OF THE MDR

The European Commission published an updated Medical Device Coordination Group (MDCG) 2020-3 Rev.1 – Guidance on significant changes regarding the transitional provision under Article 120 of the MDR in May 2023. Changes were made throughout the guidance document to align it with Regulation (EU) 2023/607 (updates to MDR/IVDR transitional provisions) and with the similar guidance document for […]