Euro Roundup: MDCG posts guidance on notified bodies

RoundupsRoundups | 11 August 2022 |  By 

The Medical Device Coordination Group (MDCG) has posted guidance on the designation, reassessment and notification of conformity assessment bodies and notified bodies.
MDCG created the guidance to support designating authorities responsible for assessing applications for medical device and in vitro diagnostic notified bodies. The text also covers the reassessment and is intended to “bring consistency and to align the working practices of the different designating authorities.”
The first section of the guidance addresses the steps leading up to the inclusion of a notified body in the NANDO database, including pre-assessment and off-site activities, onsite assessment activities, post-onsite assessment activities and the decision on the designation. The second section covers the notification in NANDO, the objection period and the validity of the designation.
MDCG also describes the reassessment process. MDR and IVDR require notified bodies to be reassessed three years after the original notification and every fourth year thereafter.
The procedure for onsite assessment of new notified bodies applies “in principle” to organizations undergoing reassessment. The reassessment will look at relevant changes to the notified body’s quality management system since the prior designation. Once the process is complete, the designating authority will update the notification in NANDO.
MDCG Guidance
Europe extends deadline for submitting nitrosamine variation applications by 12 months
European authorities have extended the deadline for submitting variation applications for changes to the manufacturing processes of chemical medicines to cut the risk of nitrosamine formation.
Under the original timeline for the response to nitrosamine impurities, confirmatory testing updating marketing authorization were supposed to occur by no later than26 September. However, the Committee for Medicinal Products for Human Use and the Coordination Group for Mutual Recognition and Decentralised Procedures - Human recently agreed to delay the deadline for updating marketing authorization.
Now, marketing authorization holders have until 1 October 2023 to file variation applications. The European Medicines Agency (EMA) said “the extension aims to enable companies to perform a thorough investigation and to establish any required risk mitigating actions in light of new scientific developments since 2020, in particular those concerning active substance-derived nitrosamines.”
Because a similar approach is being taken to certificates of suitability, the European Directorate for the Quality of Medicines & HealthCare (EDQM) has extended the deadline for required revisions until 1 October 2023. EDQM and EMA are encouraging companies to submit variation applications as soon as they conclude their investigations and before the extended deadline.
EDQM Notice, EMA Update
AEMPS explains how drugmakers can gain exemptions from Spanish air temperature rules
The Spanish Agency of Medicines and Medical Devices (AEMPS) has explained how facilities that make, store, distribute or supply medicines can benefit from an exemption to a law that places restrictions on the air temperature in buildings.
With all European Union countries agreeing to reduce their natural gas use to mitigate a potential energy crisis linked to Russia’s invasion of Ukraine, the Spanish government recently passed a law limiting indoor heating to 19 degrees Celsius and air conditioning to 27 degrees Celsius.
Because the commonly accepted temperature for stories drugs and active pharmaceutical ingredients (API) is 25 degrees Celsius, companies that manufacture, store, distribute or supply medicines and API are exempted from the new law, according to AEMPS. They must, however, ensure that the storage and manufacture areas are separated physically from adjoining premises.
AEMPS Notice (Spanish)
UK outlines plans for MHRA fast-track ethics review in push to simplify clinical trial approvals
The UK government has outlined plans to implement a fast-track ethics review as part its plans to reform their clinical trials system.
“A single, simplified approval service for clinical trials in the United Kingdom will be developed, including the implementation of a fast-track ethics review in the Medicines and Healthcare products Regulatory Agency’s (MHRA) and the Health Research Authority’s combined process. NHS England is implementing the National Contract Value Review to expedite the costing elements of the contracting process in NHS trusts to prevent delays,” according to James Morris, parliamentary undersecretary for health and social care.
After consulting on legislative changes for clinical research, MHRA is now preparing the government’s response and secondary legislation. In parallel, the National Institute for Health and Care Research (NIHR) is expanding its support through its clinical research network to help researchers design studies. NIHR is also investing in ways to identify potential participants and deliver decentralized clinical trials.
Morris Statement
France’s ANSM tweaks guidelines on penalties for noncompliance with drug shortage rules
The French National Agency for the Safety of Medicines and Health Products (ANSM) has updated the guidelines on the financial penalties for noncompliance with rules intended to stop drug shortages.
France enacted a law to combat drug shortages in 2020. After consulting with the industry and other stakeholders, ANSM has updated its guidelines on determining financial penalties, including a five-step process for calculating financial penalties.
The process describes the factors that determine the setting of the basic amount, explaining that issues related to shortages are subject to a 20% increase to the initial penalty. Other sections cover modifiers related to the severity and duration of the disruption and the actions of the company. ANSM will increase the fine for intentional and repetitive breaches and reduce it if a company is cooperative.
In the final step, ANSM can add a penalty payment for each day of the supply shortage. The penalty cannot exceed 30% of the company’s average daily turnover in France for the last financial year.
ANSM Notice (French)
Other news:
MHRA is set to decommission the eSUSAR website at the end of September. After that date, the agency will only accept reports of suspected unexpected serious adverse reactions (SUSARs) via Individual Case Safety Report (ICSR) Submissions. ICSR Submissions is replacing the EudraVigilance website and is the route for submitting single SUSAR reports. Bulk reports go through the MHRA Gateway. MHRA Guidance
MHRA and the Committees of Advertising Practice have issued a joint enforcement notice about the promotion of Kenalog as a hayfever treatment on social media. Kenalog is a prescription-only medicine that cannot be directly or indirectly advertised to the public. MHRA Notice


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