To protect consumers against potential health risks arising from the consumption of food supplements and to ensure that they are not provided with misleading information, food supplements are covered by European and national laws and regulations on food safety.
Food supplements are concentrated sources of nutrients (i.e. mineral and vitamins) or other substances with a nutritional or physiological effect that are marketed in “dose” form (e.g. pills, tablets, capsules, liquids in measured doses). Food supplements are intended to correct nutritional deficiencies, maintain an adequate intake of certain nutrients, or to support specific physiological functions. They are not medicinal products and as such cannot exert a pharmacological, immunological or metabolic effect.
Food supplements are only intended to ‘supplement’ people’s diets and not replace healthy foods. The regulation of food supplements makes clear that food supplements are not intended to replace a varied and balanced diet and food supplements packaging is required to state this information.
Because food supplements are considered as food, it is the responsibility of the manufacturer, importer, supplier or distributor to ensure that a food supplement placed on the market is safe.
EU Member States may, for monitoring purposes, request notification of the placing on the market in their territory of a food supplement. Once the product is on the market, the competent authority of the Member State may monitor its use and safety in that territory.
Following an assessment by the European Food Safety Authority (EFSA), the European Commission may take a decision to include a certain substance in a list of substances whose use in foods is prohibited, restricted or under scrutiny. This may happen when the addition of a substance in food products increases its exposure to levels greatly exceeding the normal consumption and/or poses a potential risk to consumers.
Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 partially harmonizes the rules for placing food supplements on the European market. The scope of the Directive includes all food supplements with certain requirements, in particular those relating to labeling particulars, which apply to all food supplements, whatever their composition.
The MDCG 2022-19 was published on December 2022. This document indicates a series of templates that should be used for performance study applications under the IVDR, while the respective EUDAMED module is not fully functional.
Safety reporting in clinical investigations of medical devices shall be performed in line with Article 80(2) of the EU MDR. On May 2020, it was published the MDCG 2020-10/1, outlining the procedures for safety reporting in clinical investigations of medical devices under the EU MDR. However, on October 2022 the Medical Device Coordination Group (MDCG) published an updated version of the MDCG 2020-10/1, the MDCG 2020-10/1 Rev 1. This article highlights the updates included in the new revision, analysing the gaps between both documents.
If a medical device manufacturer is not established in a Member State, the devices can only be placed on the Union market if the manufacturer designates an authorised representative. The authorised representative plays a pivotal role in ensuring the compliance of the devices with EU regulation, serving as point of contact. The obligations and responsibilities of authorised representative are outlined on Article 11 of both MDR and IVDR, but clarification of relevant requirements is described in MDCG 2022-16 of October 2022.
ISO Standards cover a huge range of activities, representing the distilled wisdom of people with expertise in their subject matter and providing the regulators with a sound basis to develop better legislation. ISO Standards are diverse, addressing from the shoe size we wear to the quality of air we breathe. The medical device sector is no exception. ISO has many International Standards and guidance documents aimed at helping the sector ensure safe and effective medical devices while meeting the multitude of national, regional and international regulatory requirements. But how exactly is a Standard developed, reviewed and withdraw?
The Commission published the Implementing Regulation (EU) 2022/2347, laying down rules for the reclassification of several active products without an intended medical purpose mentioned in MDR annex XVI.
The proposed amendments aim to maintain patients’ access to a wide range of medical devices while ensuring the transition to the new framework. The ammendments proposal aims to extend the current transition period (Article 120 of the MDR), and it also deletes the ‘sell-off’ deadlines of both MDR and IVDR. The extension is staggered depending on the risk class of the device – until December 2027 for high-risk devices and December 2028 for medium and lower-risk devices.
