Euro Roundup: MDCG issues guidance on in-house devices under MDR and IVDR

RoundupsRoundups | 12 January 2023 |  By 

The Medical Device Coordination Group (MDCG) has released guidance on how the medtech regulations apply to devices and diagnostics that are manufactured and used by health institutions in the European Union.
Such in-house medical devices are exempt from most of the provisions of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR), the exception being the general safety and performance requirements set out in Annex I. However, to benefit from the exemptions, health institutions must meet the conditions set out in Article 5(5) of the regulations.
MDCG’s latest document provides guidance on the terms used in Article 5(5) of MDR and IVDR. The text explains which devices are referred to in the section, plus details such as how to understand the terms “manufactured and used” and the need for compliance with relevant general safety and performance requirements.
The largest section of the text covers the question of what is an appropriate quality management system (QMD) for in-house devices. Health institutions must manufacture and use in-house devices under an appropriate QMS. The MDCG guidance features examples of areas covered by an appropriate QMS, such as risk management and traceability, as well as details of what is required in each area. 
MDCG Guidance
EMA adopts ICH guideline on continuous manufacturing
The European Medicines Agency (EMA) has adopted final international guidance on the continuous manufacturing of drug substances and drug products, positioning the text to come into effect in July.
Continuous manufacturing involves the continuous feeding of input materials into a system and removal of the output materials from the manufacturing process. The approach is distinct from the more widely used stop-start batch production technique, leading the International Council for Harmonisation (ICH) to develop the Q13 guideline on continuous manufacturing.
EMA’s Committee for Medicinal Products for Human Use adopted the guideline last month and released it to the public last week. The final text explains how scientific approaches such as control strategy and process verification apply to continuous manufacturing, and the regulatory expectations in areas including drug substance and drug product stability and pharmaceutical quality systems.
The final guidance covers the same ground as the draft version that EMA released for consultation in 2021 but features changes throughout the text. The revisions include new information about regulatory expectations for the stability data package. As in the draft, the final guideline states that the expectations “generally do not differ” between continuous and batch production but officials have added new details about chemical drug substances and drug products.
In two new bullet points, the guideline explains that stability batches may be produced from shorter manufacturing runs if the control strategy, mass flow rate and equipment are representative of the commercial process, and “it is demonstrated that a state of control is established and maintained when the process operates over the longer commercial run times.”
If manufacturers plan to increase output by means other than longer runs, for example by using larger equipment, they should justify their approach for defining primary stability batches. The ICH guideline encourages applicants “to discuss their scale-up and primary stability batches approach with regulatory authorities.”
In annexes to the guideline, ICH provides more specific information about continuous manufacturing of chemical entities and therapeutic proteins. ICH has made some changes to the annexes, notably to the section on therapeutic proteins. That annex now states that “the number or range of cell bank vials used to produce the specified number of drug substance batches should be defined” and that vials “should be traceable to the output drug substance batches.”
ICH Guideline
EMA clarifies impact of good distribution practices on brokers active outside of the EU
EMA has updated its guidance on good distribution practices (GDPs) to clarify how the rules apply to brokers that are active outside of the European Economic Area (EEA).
The document includes two new queries about GDP requirements. The new questions address whether a broker can broker activities between parties outside the EEA and whether a broker can broker activities for medicinal products without a marketing authorization in the EEA, but with a marketing authorization outside the EEA.
The answer to both questions is no. In explaining the answers, EMA pointed to its 2013 guidelines on GDPs. The guidelines require both suppliers and customers to be located in the EEA. Brokering activities between suppliers and customers outside the EEA fall outside the scope of the EU legislation. Similarly, a medicinal product must have a marketing authorization in at least one EEA country for the rules to apply.
Updated Q&A
Ireland’s HPRA outlines response to tripling of demand for some cold and flu medicines
Ireland’s Health Products Regulatory Authority (HPRA) has outlined the actions it is taking to ensure the availability of medicines for seasonal illnesses amid a doubling and tripling of demand for some cold and flu products.
Factors including the high level of respiratory illnesses in the community have caused demand for cold and flu products to climb to well above what is typical for this time of year in Ireland. In response, HPRA is “engaging with all stakeholders, including suppliers, with a view to ensuring a coordinated response to this increased demand” and ensuring suitable medicines remain available to treat all patients.
The presence of multiple forms, strengths, brands and generic versions of the products used most often in Ireland means that, while some individual medicines are in short supply, alternatives are available to ensure continuity of treatment, HPRA said. The authority is asking healthcare professionals and patients not to order extra quantities of medicines or issue additional prescriptions.
HPRA Statement
Swissmedic tracks increase in illegal imports of nasal sprays and laxatives, issues warning
The Swiss Agency for Therapeutic Products (Swissmedic) has warned of a risk of dependence associated with the long-term use of nasal sprays and laxatives after seeing an increase of illegal imports of the drug products.
Swissmedic has regularly seized illegal imports of nasal sprays or certain laxatives over the past few years. Recently, the agency has seen a rise in the confiscation of “shipments with large quantities of medicines ordered by Swiss customers from foreign online pharmacies.”
Swiss pharmacies do not sell large quantities of the products over the counter because of the risks, leading buyers to move online. Because Swiss therapeutic products legislation does not generally apply overseas, it is hard for Swissmedic to enforce measures designed to protect health on imports.
“Swissmedic notifies the competent foreign regulatory authorities of mail-order pharmacies that supply Swiss customers with harmful quantities of nasal sprays or certain laxatives and that therefore act irresponsibly. Nevertheless, alarming quantities of over-the-counter preparations can still be obtained from certain foreign mail-order pharmacies without any consultation or limit,” the agency wrote.
Swissmedic Notice
Other News:
EMA is set to start a pilot to enable manufacturers of high-risk medical devices to access scientific advice from the expert panels next month. The scientific advice will cover clinical development strategies and clinical investigation proposals for “class III and IIb high-risk medical devices meant to administer or remove medicinal products from the body.” EMA will share more information soon. EMA Notice


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