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12 January 2026

The European Commission proposes targeted revisions to the EU regulations on medical devices: Towards simpler and more effective rules?

By Tobias Dolle, Stella Nalwoga, and Paolo R. Vergano

On 16 December 2025, the European Commission (hereinafter, Commission) adopted a Proposal for a Regulation to simplify rules on medical and in vitro diagnostic devices, aimed at simplifying the current rules for medical devices in order to “reduce the administrative burden on manufacturers and enhance the predictability and cost-efficiency of the certification procedure”, while also “preserving a high level of public health protection and patient safety”. 

This article provides an overview of the Commission’s proposal, assesses whether the proposed changes address specific trade concerns raised by Members of the World Trade Organization (hereinafter, WTO) regarding the current EU rules, and discusses potential implications for businesses.

The EU’s regulatory framework for medical devices and in vitro diagnostic 

The EU’s Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices(hereinafter, Medical Devices Regulation) and Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices (hereinafter, In Vitro Diagnostic Medical Devices Regulation) govern the development, production, and distribution of medical devices and in vitro diagnostics within the EU. Medical devices and in vitro diagnostic medical devices are products ranging from sticking plasters, syringes, surgical masks, and eyeglasses, to wheelchairs, mobile medical applications, and body scanners. According to the Commission, the EU’s medical devices sector is the second largest in the world with more than 38,000 companies, 90% of which are small and medium-sized enterprises.

The Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation entered into force in 2021 and 2022, respectively, and introduced stricter requirements for the designation and oversight of notified bodies, which refers to organisations designated by an EU Member State to assess the conformity of certain products before their placing on the market and the conduct of conformity assessment activities, which refers to the process of verifying that products meet relevant technical regulation or standards.

The Regulations also introduced stricter requirements for the generation of clinical evidence supporting the safety and performance of devices, and the post-market oversight of devices. In 2025, the Commission carried out a targeted evaluation of these regulations, which revealed “several unintended consequences”, including an increased administrative burden, longer timelines, and increased costs to achieve market access, as well as an inconsistent application of regulatory requirements, such as conformity assessment, across EU Member States. 

At a meeting of the WTO Committee on Technical Barriers to Trade (hereinafter, TBT Committee) in June 2025, India had raised specific trade concerns regarding the EU’s regulations on medical devices and in vitro diagnostic medical devices, notably that: 1) The limited capacity of the notified bodies had created a bottleneck in conformity assessments, leading to delays in certification of devices and posing market access risks for manufacturers; 2) The clinical evaluation requirements for low-and medium-risk medical devices were more trade restrictive than necessary; and 3) The need for a more balanced, proportionate, and internationally harmonised implementation of the regulations. In response, the EU had informed the Committee that it was conducting an evaluation of the regulations and invited feedback from both EU and non-EU stakeholders.

Overview of the Commission’s proposal

In its explanation of the proposed Regulation, the Commission groups the proposed amendments according to eight areas: 1) “Simplification and proportionality”, covering the validity of certificates and recertification, clinical evidence, non-clinical data and clinical data, repackaging and relabelling, and classification rules; 2) “Reduction of administrative burden”, including regarding the scope of devices for which the manufacturer must provide a summary of safety and clinical performance, and the frequency according to which manufacturers are obliged to update periodic safety reports; 3) “Innovation and availability of devices for special patient groups or situations”; 4) “Predictability and cost-efficiency of certification”, covering conformity assessment procedures, clinical evaluation consultation procedure, and notified body fees; 5) “Coordination within decentralised system”, covering designation, monitoring and coordination of notified bodies; 6) “Further digitalisation”; 7) “International cooperation”; and 8) “Interplay with other union legislation”.

Recital 25 of the proposed Regulation explains that the notified bodies exercise a key function in the medical device regulatory system as regards the conformity assessment and the issuance of a certificate, which is a prerequisite for market access. Pursuing the “simplification and proportionality” of certification, the proposal foresees, inter alia, to remove the 5-year maximum period of validity of certificates and instead stipulates that “certificates shall not be limited in time, unless in exceptional cases where the notified body considers it necessary to limit the period of validity based on duly justified grounds”. 

Additionally, Recital 30 of the proposed Regulation explains that medical devices fall in different classes depending on their level of risk. In order to ensure greater “predictability and cost-efficiency of certification” with respect to the conformity assessment procedures, the Commission proposes to reduce the involvement of notified bodies in the conformity assessment of lower and medium risk devices “so that it is proportionate to the risk class of the device”. For example, the Commission proposes that notified body involvement be removed for low-risk class I “sterile devices”, such as personal protection kits. 

With respect to proposals in the area of “international cooperation”, Recital 47 of the proposed Regulation states that, “to a large extent”, the EU’s regulatory system for medical devices “reflects guidelines developed in the framework of the International Medical Device Regulators Forum (IMDRF)”, a voluntary group of regulators from around the world that aims to “accelerate international regulatory harmonisation and convergence in the field of medical devices and in vitro diagnostic medical devices”.

However, in order to “increase efficiency, reduce duplication of regulatory efforts and promote global convergence”, the Commission proposes a new Article for the Medical Devices Regulation, which would allow it to “sign administrative arrangements” with third countries and international organisations and to participate in “reliance mechanisms” to “enable the use of regulatory assessments, inspections, and decisions” from third countries or international bodies by notified bodies in the EU, provided they ensure “equivalent” health and safety protection. If adopted and implemented in practice, the proposed mechanisms for international cooperation could reduce duplicative conformity assessment procedures for EU non-manufacturers. 

Reducing the impact of conformity procedures on trade

The mandatory conformity assessment procedures under the EU’s regulations on medical devices and in vitro diagnostic medical devices have important implications for businesses seeking to access the EU market. Rules on conformity assessment procedures are provided in the WTO Agreement on Technical Barriers to Trade (hereinafter, TBT Agreement). Article 5.1.2 of the TBT Agreement requires WTO Members to ensure that conformity assessment procedures are “not prepared, adopted or applied with a view to or with the effect of creating unnecessary obstacles to international trade”.

In this context, the Commission’s proposal appears to respond to concerns raised in the June 2025 meeting of the WTO TBT Committee regarding the limited capacity of the notified bodies and the trade restrictiveness of the clinical evaluation requirements for low-and medium-risk medical devices by, inter alia, reducing the involvement of notified bodies in certain classes of lower-and medium-risk devices, and removing repeated recertification. 

Furthermore, the proposed introduction of new provisions on international cooperation is particularly relevant to the broader objectives underlying Article 6 of the TBT Agreement, which encourages WTO Members, wherever possible, to accept the results of conformity assessment procedures carried out in other WTO Members. However, the proposed provisions do not establish an obligation for the EU to recognise or accept third-country conformity assessment results for market access purposes. Instead, they provide an enabling framework for administrative cooperation and participation in “reliance mechanisms”, the outcomes of which are to be “taken into consideration” by notified bodies in the implementation of the EU’s regulations on medical devices. 

Outlook 

The Commission’s proposals will now be submitted to the European Parliament and the Council of the EU for their consideration, followed by inter-institutional trilogue negotiations to reach agreement on a commonly agreed text. Stakeholders are advised to monitor proceedings closely and to engage strategically at both the EU and EU Member State levels. 

For any additional information or legal advice on this matter, please contact Paolo R. Vergano 

Thailand’s Customs Department issues new Notification simplifying Customs procedures for vessel transshipment at the Laem Chabang Port

By Imelda Jo Anastasya, Pattranit Chantaplaboon, and Paolo R. Vergano

On 28 November 2025, Thailand published Notification of the Customs Department No. 213/2568 (2025) Regarding Customs Procedures on Vessel Transshipment for Shipping Lines or Shipping Agents at Laem Chabang Port Customs Office via an Electronic System (hereinafter, Notification No. 213/2568) in its Government Gazette. Effective from 1 December 2025 to 30 November 2026, Notification No. 213/2568 aims at facilitating trade and enhancing logistics procedures at the Laem Chabang Port, notably by simplifying the documentation requirements for obtaining a transshipment declaration number, which is required before goods may be transferred to another vessel.

This article discusses Notification 213/2568, its divergence from the general Customs procedures for transshipment in Thailand, and the implications for businesses operating through Laem Chabang Port.

Thailand’s general framework for Customs procedures for transshipment 

Effective since 13 November 2017, Thailand’s general framework for Customs procedures for vessel transshipment is set out in Notification of the Customs Department No. 140/2560 (2017) Regarding Electronic Customs Formalities for Transshipment (hereinafter, Notification No. 140/2560). Under Notification No. 140/2560, persons registered with Thailand’s Customs Department as transshipment applicants must submit a manifest containing information on inbound and outbound transshipment cargo, as well as a list of transshipment containers. The manifest must be submitted electronically through the Thailand National Single Window (hereinafter, NSW), a centralised platform for streamlined data sharing and processing.

Upon the cargo’s arrival at a Thai port, applicants must obtain a transshipment declaration number for the goods to be transferred from one vessel to another by electronically submitting various documents, including an application for transshipment approval, an electronic registration form, a surety bond agreement, as well as the list of inbound and outbound transshipment cargo and the list of transshipment containers already included in the manifest.

Trade frictions at Thailand’s main port

The Laem Chabang Port, located in the eastern part of Thailand, is the largest and main deep-sea container port in Thailand and is actively positioning itself as a regional transshipment hub for ASEAN. Having surpassed the Bangkok Port in capacity, the Laem Chabang Port serves as the country’s primary port, with strategic links to major transport corridors that make it a key gateway linking Thailand to markets in Europe, China, and the Americas.

However, vessel transshipment procedures at the Laem Chabang Port, as implemented under Notification No. 140/2560, have been criticised as “ineffective” by the Bangkok Shipowners and Agents Association (i.e., Thailand’s trade association representing, inter alia, shipping lines, agents, and other maritime-related businesses) and the Thai Chamber of Commerce. 

Businesses argue that the duplication of documentary requirements for submitting the manifest and obtaining the transshipment declaration number had made the shipping process unnecessarily complicated, resulting in delays, higher administrative costs, and operational inefficiencies. Traders, therefore, had advocated for a “single document” model, under which transshipment applicants would only be required to submit the container list to obtain a transshipment declaration number. A lengthy Customs inspection process further increases dwell time and congestion at the port. Cumulatively, these administrative practices reduce the port’s competitiveness compared to other regional hubs, such as the Port of Singapore, which is considered to have more efficient Customs procedures.

On 28 February 2023, the Thai Chamber of Commerce submitted proposals to the Thai National Logistics and Service Management System Development Committee to facilitate vessel transshipment and reduce business logistics costs, including: 1) A “one-year trial” of a “Transshipment Sandbox” with simplified Customs procedures at the Laem ChabangPort; and 2) The removal of Sections 102 and 103 of Thailand’s Customs Act B.E. 2560 (2017), which provide for the automatic forfeiture of transhipped or transit goods left in a Thai port for more than 30 days. 

Enhanced Customs procedures under Notification No. 213/2568

Acting on these proposals, the Thai National Logistics and Service Management System Development Committeeissued Notification No. 213/2568, establishing the “Transshipment Sandbox” as a one-year trial from 1 December 2025 to 30 November 2026. Notification No. 213/2568 seeks to facilitate trade by streamlining Customs procedures at the Laem Chabang Port, notably by reducing duplicative documentation requirements and lengthy Customs inspections.

With respect to the documentation requirements, Notification No. 213/2568 reduces the number of documents required to obtain a transshipment declaration number from eight listed under Notification No. 140/2560 to only four, namely: 1) The vessel schedule; 2) The shipment manifest identifying the shipping agents legally responsible for specific containers or bulk cargo on a vessel prior to its arrival; 3) The container list; and 4) The manifest specifying the port of origin and destinations outside of Thailand.

As for the Customs inspections, Notification No. 213/2568 introduces an exemption from inspections at the port unless a Customs officer identifies grounds for suspicion, such as a false declaration of product descriptions or of the origin. This shift to a more risk-based inspection approach is intended to reduce delays in Customs clearance and mitigate the risk of automatic forfeiture of transhipped or transit goods under Thailand’s Customs Act.

Notification No. 231/2568 appears consistent with Thailand’s commitments under the WTO Agreement on Trade Facilitation (hereinafter, TFA). The adoption of a risk-based Customs inspection regime, under which transshipment cargo is exempt from routine inspections in the absence of specific grounds for suspicion, is consistent with Article 7.4 of the TFA, which requires WTO Members to adopt risk management systems that focus Customs control on high-risk consignments, while expediting the release of low-risk consignments.

Additionally, the reduction in the number of documents for obtaining a transshipment declaration number appears to align with Article 10.1 of the TFA, which requires WTO Members to review import, export, and transit formalities and documentation requirements with a view to simplifying relevant requirements and reducing the time and cost of compliance. Overall, Notification No. 213/2568 has the potential to advance key objectives of the WTO Agreement on Trade Facilitation aimed at expediting the movement, release, and clearance of goods.

Implications for businesses and outlook

While Notification No. 213/2568 is implemented as a time-limited “Transshipment Sandbox” and applies only to the Laem Chabang Port, it represents a positive step towards facilitating trade and reducing procedural frictions that could undermine the efficiency of transit operations. If the temporary measures introduced under Notification No. 213/2568were to prove successful in streamlining Customs procedures at the Laem Chabang Port, the “Transshipment Sandbox” could, after its one-year trial, be institutionalised and expanded into a national standard applicable also to the other ports in Thailand.

As Thailand is currently the only ASEAN Member State to have introduced an electronic process for obtaining a transshipment declaration number, the “Transshipment Sandbox” could also serve as a reference point for other ASEAN Member States seeking to streamline transshipment procedures. For businesses, this would signify a shift from a pilot initiative to an operational reality in which Thai ports can attract more global shipping routes for both transshipment operators and traders.

For any additional information or legal advice on this matter, please contact Paolo R. Vergano 

Rejected health claims highlight need for a “cause-and-effect relationship” between the consumption of food and the claimed health benefit

By Amanda Carlota, Ignacio Carreño García, and Tobias Dolle

On 5 November 2025, the European Commission (hereinafter, Commission) refused to authorise two health claims related to certain food products. Commission Regulation (EU) 2025/2222 prohibits the Spanish company Cárnicas Joselito S.A. from including in the labelling, presentation, and advertising of Joselito ham, an Iberian ham characterised by a high content of oleic acid, the health claim “The intake of Joselito ham produces a health benefit by causing an increase in antioxidant substances in the body, reducing blood pressure and plasma triglycerides, producing a decrease in oxidative stress and a preventive effect in diseases related to the cardiovascular and intestinal systems”. Meanwhile,Commission Regulation (EU) 2025/2223 prohibits producers of citicoline (CDP-choline) inner salt, a naturally occurring compound, from using the health claim “Citicoline intake supports memory function in healthy middle-aged and elderly persons encountering age-related memory impairment”.

Using these two rejected health claims as illustrative examples, this article provides an overview of the authorisation process for health claims in the EU, highlights the crucial role of the European Food Safety Authority (hereinafter, EFSA), and provides guidance for food business operators. 

Health claims and the relationship between food and health 

A health claim is defined in Article 2(5) of Regulation (EC) No 1924/2006 of the European Parliament and of the Council on nutrition and health claims made on foods (hereinafter, Health Claims Regulation) as “any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health”.

The EU’s Health Claims Regulation classifies health claims into three categories: 1) ‘Function’ claims relating to the growth, development, and functions of the body, psychological and behavioural functions, or slimming or weight control; 2) ‘Reduction of disease risk’ claims regarding the significant reduction of a risk factor in the development of a human disease; and 3) Claims referring to children’s development. The rejected health claims for Joselito ham and citicoline were both ‘reduction of disease risk’ claims. 

Health claims that have been authorised by the Commission, as well as their conditions of use and applicable restrictions, are included in the EU Register of Health Claims. The Register also includes non-authorised health claims and the reasons for their non-authorisation.  

The role of the European Food Safety Authority

Article 15(2) of the Health Claims Regulation provides that an application for authorisation of a health claim must be submitted to the national competent authority (hereinafter, NCA) of an EU Member State. The NCA then forwards valid applications (i.e., those that include all of the requirements listed in Article 15(3) of the Health Claims Regulation) to the EFSA’s Panel on Nutrition, Novel Foods, and Food Allergens (NDA Panel), which conducts a scientific assessment “of the highest possible standard” of the health claim.  

In 2021, the EFSA NDA Panel published its General scientific guidance for stakeholders on health claim applications, which lists the three key criteria that the Panel must consider when evaluating health claims, namely that: 1) The food product is “defined and characterised”; 2) The claimed health benefit is either “based on the essentiality of a nutrient” or “defined and is a beneficial physiological effect for the target population and can be measured in vivo in humans”; and 3) A “cause-and-effect relationship” is established between the consumption of the food product and the claimed health benefit. These requirements are based on the definition of a health claim in Article 2(5) of the Health Claims Regulation,which presupposes the existence of a relationship between a food category, a food, or one of its constituents, and the claimed health benefit.

If the EFSA NDA Panel finds that all three criteria have been fulfilled, the health claim is considered to be compliant with the requirements of the Health Claims Regulation. According to Article 17(1) of the Health Claims Regulation, the Commission must then “take into account” the EFSA’s opinion when drafting decisions on permitted health claims. The law further states that, when a draft decision is “not in accordance” with the EFSA’s opinion, the Commission must provide an explanation for the differences.

As of 2023, “more than 70%” of evaluated health claims had been rejected by the Commission due to a lack of scientific evidence based on the EFSA’s opinion. If the Commission agrees with the EFSA’s opinion that a health claim complies with the criteria of the Health Claims Regulation, it will be included in the EU list of permitted health claims on the basis of a Commission Implementing Act.

In general terms, authorised health claims may be used by any food business operator, unless the applicant had previously applied for data protection under Article 21 of the Health Claims Regulation (see Trade Perspectives, Issue No. 17 of 22 September 2025). In this context, Article 17(5) of the Health Claims Regulation provides that “Health claims included in the lists provided for in Articles 13 and 14 may be used, in conformity with the conditions applying to them, by any food business operator, if they are not restricted for use in accordance with the provisions of Article 21”.

For both Joselito ham and citicoline inner salt, the EFSA NDA Panel had concluded that the first two criteria had been met, namely that both the foods and the claimed effects had been properly characterised. However, both applications had failed to meet the third criterion, as no cause-and-effect relationship had been established between consumption of the food products and the claimed health benefits.

After weighing the evidence presented, the EFSA NDA Panel noted that, for Joselito ham, “no human intervention studies from which conclusions could be drawn for the scientific substantiation of the claim” had been provided by the applicant, while, for citicoline inner salt, “no convincing evidence” had been provided by the applicant “for a mechanism by which the dietary intake of citicoline or any of its components, in addition to their endogenous synthesis, could have a beneficial effect on memory function in older adults with age-associated memory impairment”. On the basis of these findings, the Commission refused the authorisation of the respective health claims. 

The need to establish the cause-and-effect relationship 

The rejection of these health claims underscores the importance of establishing a causal link between the consumption of the food product and the claimed health benefit. Food business operators intending to apply for authorisation of a health claim must ensure that the dossiers they submit for assessment contain convincing evidence of such causality.

Section 7.3 of the EFSA NDA Panel’s guidance document states that each cause-and-effect relationship is assessed by the Panel “separately on a case by case basis for specific claim applications”. However, the guidance document underscores that “Pertinent human studies are an absolute requirement for the scientific substantiation of health claims, and pertinent human efficacy studies are at the top of the hierarchy that informs decisions on substantiation”. As a consequence of Cárnicas Joselito S.A.’s failure to include such human studies in its application, the EFSA NDA Panel had found no cause-and-effect relationship between consumption of Joselito ham and the claimed reduction in LDL-cholesterol concentration, blood pressure, and risk of coronary heart disease. 

The EFSA NDA Panel’s guidance document further states that “The reproducibility of the effect of the food/constituent, as indicated by the consistency of the findings (within and across studies), and the biological plausibility of the effect also need to be considered”. With respect to citicoline inner salt, the EFSA NDA Panel had observed that “One randomised controlled study (RCT) (Nakazaki et al., 2021) showed that citicoline consumed at doses of 500 mg/day for 12 weeks improved episodic memory as compared to placebo and did not affect short-term or working memory”, but then found that “This beneficial effect of citicoline on episodic memory, however, was not confirmed in a second RCT using higher daily doses of citicoline (1 g) for a similar period”. Therefore, the EFSA NDA Panel found that the applicant Edga Pharma had been unable to demonstrate the reproducibility of the claimed improvement on episodic memory. 

To maximise the likelihood of obtaining an authorisation for a health claim, prospective applicants are advised to carefully consult the EFSA NDA Panel’s guidance document to ensure that their applications are accompanied by the necessary human studies to support their health claims and to seek legal and scientific support as necessary.

For any additional information or legal advice on this matter, please contact Ignacio Carreño Garcia

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Imelda Jo Anastasya, Amanda Carlota, Ignacio Carreño García, Pattranit Chantaplaboon, Joanna Christy, Tobias Dolle, Alya Mahira, Stella Nalwoga, and Paolo R. Vergano contributed to this issue.

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