The Medical Device Coordination Group (MDCG) recently updated its guidance on interpreting Article 54(2)b of the Medical Devices Regulation (MDR), which discusses the criteria that exempt devices from the premarket clinical evaluation consultation procedure with expert panels. According to the text of the article, the clinical evaluation consultation procedure shall not been required when: (a) a firm is renewing certificate under MDR; (b) a device “has been design...

The Medical Device Coordination Group (MDCG) on Wednesday issued guidance to help notified bodies perform audits during the pandemic, including, under certain circumstances, remote audits. The 5-page guidance deals strictly with surveillance audits under the medical devices directives, audits conducted for recertification purposes under the directives, in cases where a manufacturer submits a change notification to a notified body that would typically require an on-site ...

This article reviews possible ramifications caused by the delay in launching the European Union’s new electronic database, the European Database on Medical Devices (Eudamed).The author discusses potential issues when clinical investigation data is not transparent or accessible. Until Eudamed is available, posting study results on other databases is recommended so manufacturers can meet requirements for clinical investigation transparency and disclosure while sharing clinic...

The European Commission on Wednesday reassured the generic drug association Medicines for Europe that member and nonmember companies can work together to battle shortages of critical hospital drugs to treat COVID-19 patients. The commission explains how generic firms may need to coordinate on stock management and distribution “so that not all undertakings focus on one or a few medicines, while others remain in under-production. Such coordination would be contrary to ant...

The EU Executive Steering Group on Shortages of Medicines Caused by Major Events is currently establishing, with the pharmaceutical industry, the i-SPOC (industry single point of contact) system to speed up interactions on drug shortages between industry and the steering group, the European Medicines Agency (EMA) said Monday. Although medicine shortages are dealt with at the national level in the EU by national competent authorities, under this new system each pharmaceu...

The European Medicines Agency (EMA) on Friday released a set of recommendations for providing Gilead’s investigational drug remdesivir under compassionate use programs to patients with coronavirus disease (COVID-19) who are ineligible for clinical trials.   EMA says it received requests from four EU member states, Estonia, Greece, the Netherlands and Romania, asking for advice on providing early access to the drug.   Initially developed as an antiviral therapy to t...

The European Commission on Friday released a proposal that would defer for a year the Medical Devices Regulation (MDR) from taking effect on 26 May. The European Parliament is expected to vote on the proposal on 16 April. With an eye toward avoiding the disruption of the device market at such a critical time, the year-long delay will not alter the substance of MDR. The delay also will “not impose new obligations on the concerned parties. It primarily aims at providing, ...

Two drugs primarily used to treat malaria, chloroquine and hydroxychloroquine, should not be used to treat coronavirus disease (COVID-19) outside of clinical trials or emergency use programs, the European Medicines Agency (EMA) said Wednesday.   The agency said there is currently no evidence for the drugs’ efficacy in treating COVID-19 and warns that both drugs can have serious side effects.   “They must not be used without a prescription and without supervision by...

The Danish Medicines Agency's Medical Devices Unit is “massively building up capacity” in the area of medical devices, the agency said Tuesday, to better deal with the incoming EU device legislation and to address rapid changes in technological development. A new fee structure will allow the devices unit to increase its staff capacity from about 14 employees to about 40 employees once all new employees have been recruited next spring. The unit will also work more closel...

With the EU’s new medical device regulation (MDR) coming into effect in less than a year, seven EU-based medical device industry groups on Wednesday called to accelerate the implementation of the regulation “to avoid severe disruption of product supply to patients and hospitals.” While acknowledging a mechanism in MDR to allow for a grace period for certain devices that must meet the 26 May 2020 deadline, the groups explain why that mechanism has two fundamental weaknes...

The RAPS Regulatory Conference Europe 2019 kicked off in Brussels Monday with a lively discussion among expert panelists representing European health authorities, notified bodies, and industry groups as well as other regulatory professionals including RAPS members from around the world. The EU’s transition to the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) was a key point of discussion as multiple panelists expressed concern about the ti...

RAPS released the updated agenda for its upcoming European conference in Brussels, 13–14 May. Among the speakers for the inaugural RAPS Regulatory Conference – Europe 2019 are representatives from the European authorities, notified bodies and trade representatives, all thought leaders and stakeholders with crucial responsibilities in the effective implementation and functioning of the changing European regulatory environment. “Europe’s regulatory environment for med...