EUROMCONTACT
EUROMCONTACT is the non-profit organisation representing the European industry of contact lenses, lens care products and accessories for contact lenses.
ID: 97208951315-46
Lobbying Activity
Response to Targeted revision of the EU rules for medical devices and in vitro diagnostics
6 Oct 2025
EuromContact, representing manufacturers of contact lenses and lens care products, welcomes the targeted revision of the MDR and its objectives to streamline and future-proof the regulatory framework by reducing the administrative burden and enhancing predictability and cost-efficiency, while preserving a high level of public health and patient safety. We strongly support this priority to enhance the predictability and cost-efficiency of the certification processes of notified bodies and consider that significant improvements must be introduced swiftly, as MDR revisions will only take effect in several years. Measures could already be implemented through an implementing act on MDR Annex VII, before amending the MDR (fixed timelines, early dialogue on clinical strategy...). In addition to the upcoming implementing act on MDR Annex VII, further guidance on the certification process could also be provided within the MDR itself to ensure consistent reviews across Notified Bodies (standardizing the forms, certification process for Annex XVI products...) We welcome the Commissions objective of proportionality, not only in conformity assessment but also in post-market surveillance. To ensure that conformity assessment requirements are more proportionate for low- and medium- risk devices, EuromContact proposes to allow notified bodies to adapt assessment depth based on risk class and device novelty, introduce a predicate device concept, allow manufacturers of class II devices to reuse prior documentation and existing evidence, allow waivers of annual biocompatibility testing when materials are unchanged and have a long-proven safety record, enable one extraction study per material to cover multiple manufacturers, adopt substantial equivalence approach for long-standing devices, base equivalence criteria on similarity. Additionally, the MDR should be amended to allow the Commission to extend the list of WET beyond class IIb implantables. We support reducing bureaucracy to focus on patient safety and quality. Proportionality should also apply to reporting obligations. EuromContact recommends reducing the number of required reports, especially for lower risk devices, prioritizing the quality of information over quantity:Merge PMS and PMCF plansn, require only one report (PSUR) instead of separate PMCF reporting, reduce the frequency of the (PSUR/ PMCF) reporting for lower-risk devices, implement flexibility in the regulation that for certain devices with proven record of safety and performance, PSUR/PMCF reporting can be eliminated. In addition to reporting obligations, further measures to reduce unnecessary administrative burden could include : - Remove the 5-year maximum validity period for QMS certificates, allowing certificates without an expiry date, as manufacturers maintain an effective post-market surveillance system. - Clarify substantial change, ensuring that manufacturers determine if a post-certification modification is substantial, with non-substantial modifications reviewed at annual audits rather than requiring immediate NB notification. - Ensure EUDAMED replaces national registrations, avoiding duplication. - Delete Article 16s final section to eliminate unnecessary restrictions on relabeling/repackaging. - Remove redundant checks when the same organization acts as both importer and distributor - Clarify certain definitions within the MDR to reduce the administrative burden of repeatedly seeking clarification (e.g. both Intended Use and Intended Purpose should be defined and used consistently across the regulation) We strongly support bringing the MDR to the digital age. Priorities include: Allowing eIFU for lay users. e-labelling for non-safety-critical information. Digitalization of documents and signatures Consistency across notified bodies and competent authorities is essential. We propose creating a single authority with decision-making power to resolve divergence. Please see position attached
Read full responseResponse to Revision of the 'New Legislative Framework'
2 Sept 2025
EuromContact, representing the European manufacturers of medical devices such as contact lenses and lens care products, supports the overall objectives of the NLF revision to improve EU product legislation by increasing harmonisation, cutting regulatory burdens and using digital tools to boost compliance and safety. As detailed in the attached paper, we specifically underline the importance of ensuring : - that the NLF revision is fully consistent with the announced revision of the Medical Device Regulation (MDR - expected end of 2025). Improving consistency in EU product legislation should be a priority in the revision process. - that the proposed scenario of increasing digital integration through the mandatory DPP does not create duplication, impose disproportionate burdens, nor has significant consequences for medical device labeling, while the MDR already establishes a comprehensive traceability framework ; - pragmatic e-IFU frameworks and to modernise the provision of IFU by enabling broader adoption of electronic formats; - fast and effective citation of product-specific harmonized standards, which are essential tools for manufacturers to demonstrate compliance with regulatory requirements; - greater consistency and predictability across notified bodies. To avoid duplication and regulatory misalignment, the NLF must be carefully coordinated with sector-specific legislation such as the MDR.
Read full responseResponse to Sustainable products - disclosure of information on unsold consumer products
10 Jul 2025
The European association representing manufacturers of contact lenses and lens care products, EuromContact, welcomes the opportunity to comment on the draft Commission implementing regulation developed under Article 24 of the Ecodesign for Sustainable Products Regulation (ESPR). Given the specific regulatory requirements applicable to medical devices, the delimitation of product categories should differentiate medical devices in the implementing act to exclude them from the scope of disclosure of information on discarded unsold consumer products. Their inclusion would not serve the intended purpose of reducing unnecessary waste but would instead: Create disproportionate administrative burden on manufacturers without addressing the environmental concerns. Fail to acknowledge that the disposal of expired contact lenses : o is mandated by law due to their limited shelf life; o reflects public health and patient safety responsibilities; o cannot be avoided or mitigated through donation or sales campaigns due to legal and logistical constraints (prescription requirements, individualized vision correction combinations, temperature-sensitive storage and transport conditions). We urge the Commission to explicitly differentiate medical devices, such as contact lenses and lens care products, from general consumer products in the implementing act under Article 24, for the reasons detailed in the attached paper.
Read full responseResponse to EU rules on medical devices and in vitro diagnostics - targeted evaluation
21 Mar 2025
The EU Medical Devices Regulation (MDR) aims to create a robust legal framework that ensures only safe and effective devices are available on the EU market, to protect patient safety and public health while supporting innovation. EuromContact fully supports these goals and, 8 years after its publication, takes this opportunity to assess the MDRs effectiveness, efficiency, relevance, coherence, and added value. Representing manufacturers of contact lenses and lens care products, the contribution focuses on the impact of the MDR on class IIa and class IIb medical devices and on annex XVI products. While the MDR has introduced significant benefits, such as a more structured regulatory system, reduced ambiguity, and improved consistency across the EU, it has also imposed substantial documentation and reporting burdens, particularly for legacy devices with long-standing safety records, without adding clear patient safety benefits for these devices. Many low-risk, well-established devices face the same stringent requirements as high-risk, novel devices, leading to disproportionate complexity. In these cases, the bureaucratic weight of MDR threatens the viability of some medical devices, especially for SMEs. Despite MDRs numerous references to a risk-based approach, its implementation fails to adequately distinguish between high-risk new technologies and stable, low-risk devices. While some positive developments, such as a focus on quality management systems (QMS) for lower-risk devices and the Well-Established Technology (WET) concept, have been introduced, the overall lack of proportionality has significantly increased costs at all steps of the lifecycle, impacting the availability of devices. This is especially true for the initial certification of a device, where risk classification has actually minimal impact : even low-risk devices must meet stringent requirements, including redundant clinical data validation, even for long-established and demonstrably safe products. This paper examines the current situation, acknowledging the ambition and strength of the MDR while highlighting its shortcomings, particularly in proportionality, clarity of requirements, harmonization, and excessive administrative burden with limited benefits. EuromContact calls for concrete measures to allow: A truly risk-based approach that ensures proportionality for devices with long-established safety records. Key requirements, such as clinical evidence, biocompatibility testing and post-market surveillance should be adapted based on a devices safety history. A focus on patient safety and quality rather than excessive bureaucracy. Clarification of the requirements for better harmonization in MDR implementation. EuromContact specifically advocates for the possibility to demonstrate that legacy contact lenses and lens care products can be considered as WET under MDCG 2020-6. This would facilitate evidence leveraging, support the use of the equivalence concept, and proportionally adjust regulatory requirements. As the transition period nears its end, some measures are more urgent than others, as they would specifically benefit the remaining devices undergoing certification. This is particularly true for the scope of WET and clinical evidence requirements. EuromContact has conducted a comprehensive review of the MDR and compiled a state-of-play analysis along with proposals for each section of the text in the attached document : 1.Identification and traceability of devices (MDR Chapter III & Annex VI) 2.Classification and conformity assessment (MDR Chapter V & Annexes VII, VIII, IX, X, XI) 3.General Safety and Performance Requirements (MDR Annex I & + II 4.) 4.Clinical evaluation and investigations (MDR Chapter VI & Annexes XIV + XV) 5.Post-market surveillance and vigilance (MDR Chapter VII & Annex III) 6.Annex XVI products 7.Miscellaneous
Read full responseResponse to Implementing regulation for electronic instructions for use for medical devices
21 Mar 2025
EuromContact welcomes the draft Implementing Regulation aimed at expanding the scope of electronic instructions for use (eIFU) for medical devices. However, we regret that the revision remains limited to medical devices intended exclusively for healthcare professionals and remains to exclude: - the products listed in Annex XVI, even those to be used exclusively by healthcare professionals; - medical devices and accessories for lay use, such as contact lenses and lens care products. The revision of the eIFU scope is rooted in the broader EU objectives of digital transformation, competitiveness, sustainability and reduction of unnecessary regulatory burden. Therefore, we urge the Medical Device Coordination Group (MDCG) to continue its work under Work Package 4: Electronic Instructions for Use of the MDCG New Technologies Subgroup in its 2024-2025 work program. As part of this agreed Work Package, we call for the collection of necessary evidence by the end of 2025 to support a future expansion of eIFU regulation to include some or all medical devices used by lay users. The strong and growing support for eIFU expansion to lay users highlights the need to sustain this momentum and ensure timely regulatory progress : - In the 2024 EU Commissions survey on eIFU, 90% of the 7 300 healthcare professionals surveyed agreed that eIFU could be provided for additional medical devices intended for lay users. They emphasized benefits such as a patient-centered approach, patient safety, compliance, and autonomy. - European associations of optometrists and ophthalmologists, including ECOO and ECLSO, support the transition towards eIFU for contact lenses and lens care products due to benefits such as improved accessibility, ease of use, real-time updates, and user-friendly interfaces. - A survey conducted in 2023 by OpinionWay for EuromContact among 1,008 contact lens wearers in the European Union found that 85% of respondents preferred eIFU for their contact lenses and lens care products. - The 2024 European Patients Forum survey on the implementation of the EU MDR calls for comprehensive, easy-to-understand information to patients about the devices they use and considers that as digital information becomes increasingly prevalent, increased availability of eIFU for patients is helpful, as long as paper-based instructions remain accessible to avoid inequalities in information access. While under the MDR, eIFU is already permitted for patients using software as a medical device, with no reported safety concerns, we see that global regulatory trends, technological advancements and sustainability considerations are leading to further develop information in digital format to ensure that patients have safe, effective, and user-friendly access to essential medical device information. The European Medicines Agency (EMA) and EU national competent authorities recently concluded a one-year pilot project on electronic product information (ePI) for human medicines. The final report, published in December 2024, concludes that the network should progress towards ePI implementation. As far as medical devices are concerned, other jurisdictions are exploring the expansion of eIFU for lay users. For example, the Australian Therapeutic Goods Administration published the outcome of its public consultation in August 2024, which indicated support to allowing eIFU to be provided for a greater range of medical devices used by both professionals and consumers. In the Asia-Pacific region, 45% of current eIFU regulations already cover both professional and home-use devices, including in South Korea, Thailand, Vietnam, and India. While we fully acknowledge the progress made with the forthcoming adoption of this draft implementing regulation, the strong support from healthcare professionals, patients, and the global momentum toward broader eIFU adoption make it essential for the MDCG to continue its work in parallel in 2025, further exploring the inclusion of lay users.
Read full responseResponse to Ecodesign for Sustainable Products - Product priorities
12 May 2023
EuromContact, the European association of contact lens and lens care manufacturers, supports the general objective of the proposal for a new Ecodesign for Sustainable Products Regulation (ESPR) to improve circularity and other environmental sustainability aspects of products. The contact lens and lens care manufacturers have already reduced waste disposal and are committed to increase recycling of materials from the production processes. The industry is also continuously seeking ways to reduce carbon emissions across the value chain and reduce water and energy consumption. However, ecodesign requirements should be consistent with patient safety requirements and the applicable sectorial legislation such as Regulation (EU)2017/745 on medical devices (MDR). Medical devices must comply with specific requirements when it comes to reusability, recycled content, remanufacturing and information provision, for instance, which should be duly taken into account when setting ecodesign requirements. >>>>> Plastic and polymers should not have common ecodesign requirements as intermediate products The JRC preliminary study on new product priorities addresses three types of possible ESPR measures: end-use product measures, intermediate product measures and horizontal measures. Among the new and horizontal measures identified as potentially suitable for first action under the ESPR, Plastic and Polymers are identified as intermediate products. EuromContact is concerned by the possibility that ecodesign requirements will be set for intermediate products, such as the polymers used to manufacture medical devices, instead of for end-use products only. Plastic and polymers are used as intermediate products in a wide range of various applications. Due to the ubiquity of these materials across sectors, it will be impossible to set relevant ecodesign requirements at this level that would be congruent with sectoral legislation such as MDR. Intermediate products are defined as products placed on the market as final products, but which require further (professional) manufacturing and/or assembly processes before being ready for their end-use. For contact lenses, polymer buttons and disks would fall under this definition. However, these intermediate products comply with very specific technical and legal requirements as materials used to manufacture medical devices, e.g. biocompatibility, that are completely different from other plastic and polymer intermediate products. EuromContact therefore believes that plastic and polymers would best be regulated under the ESPR by regulating its use in end-use products/applications. Some of the proposed product aspects to regulate under ESPR could not be addressed by a common set of requirements for all plastic and polymer intermediate products. Common requirements across sectors such as ease of repair and maintenance, performance requirement on minimum recycled content in the product/ in plastic and polymers, ease of remanufacturing or performance requirement on minimum recycled content per unit/tonne of product, could not be set for intermediate products used to manufacture medical devices without negatively impacting patient safety and provision of healthcare. >>>>>> Horizontal measures adapted to the characteristics of each product category, especially for medical devices Cross-cutting measures, such as durability, recyclability and recycled content, that can cover groups of product categories demonstrating a degree of technical similarity, have also been identified in the JRC preliminary study on new product priorities. EuromContact emphasizes that the ecodesign requirements should differ and be adapted to the characteristics of each product category within the horizontal measures. On several aspects including durability, recyclability and recycled content, medical devices have specific constraints for patient safety reasons.
Read full responseResponse to Review of the requirements for packaging and feasibility of measures to prevent packaging waste
24 Apr 2023
EuromContact strongly supports the general objective for the revision of Directive 94/62/EC on Packaging and Packaging Waste to transform it into a regulation and tackle the environmental impact of packaging and packaging waste. The contact lens and lens care manufacturers have substantially minimized the packaging for their products. The industry is continuously seeking ways towards safe, sustainable and recyclable packaging materials, be it paper-based or recycled materials. Manufacturers are also committed to raise public awareness of the proper disposal of end-of-life products, exploiting already existing or new recycling schemes. In order to provide a clear legal framework throughout the EU, EuromContact insists on the fact that the review must be carried out in line with the following policy objectives : >>>>>>>>>consistent requirements between sectorial legislation such as Regulation (EU)2017/745 on medical devices and the packaging and packaging waste regulation ; >>>>>>>>>>> a well-functioning Internal Market through fully harmonized rules on packaging waste and sorting labelling. The following proposals aims : >>>>>>>>at increasing the consistency between the regulation on packaging and the medical devices regulation (MDR) : Medical Devices such as contact lenses and lens care products are governed by the Medical Devices Regulation. Specificities of medical devices should be taken in consideration when setting new requirements through the packaging and packaging waste regulation. For instance, the MDR in its Annex I provides labeling and packaging requirements specific to the medical devices sector. > Recyclability (article 6) : the derogation for contact-sensitive plastic packaging is welcomed and should be extended to other material such as aluminium > Recycled content (article 7) : the exemption for contact-sensitive plastic packaging of medical devices is a necessity > Packaging minimization (article 9) : eIFU and proportionate labelling requirements would help to limit packaging size and reduce waste. EuromContact thinks that packaging minimization should remain a target when setting additional labelling requirements which increase the size of the packaging to be affixed. For instance, the requirements set in the draft delegated regulation amending MDR as regards the assignment of Unique Device Identifiers for contact lenses increases the size of the information to encode in the labelling in a disproportionate way that challenges the packaging minimization objectives. When it comes to article 11 of the regulation on packaging and packaging waste, it is mentioned that where EU legislation requires information on the packaged product to be provided via a data carrier, a single data carrier shall be used for providing the information required for both the packaged product and the packaging. It should be ensured that a single data carrier could provide the information required for both the medical device and its packaging without misleading patients and health care professionals. Conflict of legislation shall be avoided by all means. >>>>>>>> at establishing harmonised EU requirements and legislation for packaging. In recent years, the industry has witnessed some diverging attempts at national level on packaging, leading to possible threat to the EU internal market. EuromContact supports the intention to harmonise across the Union to the greatest extent possible. However, we remain concerned that this harmonisation will be limited and that many provisions in the text would allow Member States to introduce specific and divergent national requirements. Diverging national experiences should be avoided at all costs, to avoid the fragmentation of the EU single market.
Read full responseResponse to Unique Device Identification assignment for highly individualised devices
18 Apr 2023
EuromContact, the European association of contact lenses manufacturers, strongly disagrees with the proposal provided in the Draft Delegated Regulation to create an alternative structure to current UDI-DI standards by grouping all contact lenses with clinical similarities under a new identifier called Master UDI. Having a single identifier for several devices would be a deviation from internationally recognised principles and would detrimentally affect traceability for the devices concerned: >>> By removing detail about the individual medical device, Master UDI breaks traceability and it cannot be compensated by encoding the clinical size of the contact lenses as Production Identifiers on the UDI label. It therefore compromises vigilance systems which use UDI-DI as the global tool and defeats systems that help prevent and detect counterfeit devices. >>>The EU would be out of sync with the rest of world in terms of medical devices traceability, thus limiting exchange of information and posing a technical barrier to trade. Creating a less specific structure to current UDI-DI standards serves only to solve the technical issue caused by proliferation of UDI-DI volume, but this goal can be achieved by more proportionate means, in accordance with UDI-DI and UDI-PI assignment rules set in MDR. > Standard contact lenses should be allowed to use UDI-DI as any other medical device covered by article 27 of MDR. > Made to order contact lenses should have the possibility to assign an UDI-DI by model recognized. EuromContact strongly disagrees with the proposed delegated act, considering that: >>>It undermines the importance of granularity to set up and maintain adequate vigilance systems (UDI-DI is the key tool for vigilance, post-market safety-related activities, and traceability of the medical device throughout distribution and use.By introducing a higher level grouping identification for contact lenses and removing detail about the individual medical device, Master UDI would compromise vigilance systems which use UDI-DI as the global tool because traceability would be broken as EUDAMED will only have Master UDI, without the UDI-DI level of traceability for contact lenses / make it difficult for trending and signal detection of issues to determine any issues with a specific clinical size, because the clinical size data will still not be in EUDAMED / defeats systems that help prevent and detect counterfeit devices as UDI-DI assignment provides the individual device identification) >>>This approach departs from a Globally accepted standard to identify medical devices while in the 2023 IMDRF Forum, the importance of Global harmonization for UDI was emphasized. >>>The Master UDI-DI is in direct violation of the regulatory logic underlying MDR Annex VI part C and the definition of UDI-DI in Annex VI part C because it changes the way in which contact lenses would be identified by making the identification less specific. >>> It does not improve patient information, nor facilitate complaints reporting. It is preferable to have clinical size information available in an easy-to-read format for patients and health care providers via labelling and accompanying documentation, rather than retrieving data via different barcodes, whose decoded data would not correspond to the format of the patients prescription. >>> The solution chosen places a disproportionate burden on manufacturers, including having to administer different UDI processes for contact lenses and other devices in the manufacturers QMS, resulting in a likely risk to patient product availability.
Read full responseResponse to Extension of the transition period for medical devices
18 Jan 2023
EuromContact agrees with the initial postulate of the proposal : many devices which may be placed on the market in accordance with the initial MDR transitional provisions are not going to be certified in accordance with that Regulation before the end of the transition period, which leads to a major risk of shortages of medical devices in the EU. EuromContact therefore welcomes the proposals to extend the validity of certificates issued under Directive 93/42/EEC and to extend the transition period during which devices that are in conformity with the Directive can be placed on the market. The proposal offers a balanced solution to give notified bodies the time needed to carry out the conformity assessments and to ensure a high level of public health protection, including patient safety and an avoidance of shortages of medical devices : - appropriate length of the extended transition period, to allow manufacturers and notified bodies to carry out the conformity assessment ; - extension subject to certain conditions to ensure that only safe devices and for which the manufacturer has taken steps to transition towards compliance MDR will benefit from the additional time. EuromContact also supports the deletion of the current sell-off date to make further available on the market devices placed on the market before the end of the transition period. This measure will prevent safe medical devices which are already on the market from having to be discarded. [Additional suggestion : consistency with the transitional period of the common specifications] This implementing regulation setting common specifications for the products without an intended medical purpose (Annex XVI), was published on December 2nd 2022. The transitional provisions for these products were defined before the proposed extension of MDR transition period. The proposal could therefore be the opportunity to strengthen consistency of transition provisions between MDR and implementing Regulation laying down common specifications, and especially to clarify that : - common specifications may contain specific transitional provisions ; - notwithstanding Article 122, Member States' measures regarding the qualification of the products covered by Annex XVI as medical devices pursuant to MDD shall remain valid until the end of the transitional period of the common specifications.
Read full response9 Feb 2022
EUROMCONTACT, the European association representing the contact lens and lens care products manufacturers’, welcomes the opportunity to provide feedback on the draft common specifications on Annex XVI products.
EUROMCONTACT feedback focuses on two critical points for the industry:
• Devices that exert both a medical purpose and at the same time a secondary non-medical purpose should be excluded from the scope of the Common Specifications;
• Clarification is needed on the transitional provisions.
Please find enclosed the detailed contribution in annex.
Read full responseResponse to Electronic instructions for use for medical devices
25 May 2021
EUROMCONTACT is the association representing the contact lens and lens care products manufacturers in the European Union. We represent more than 90% of the soft contact lens and 80% of the contact lens care products, and more than 50% of the rigid contact lenses in the European market.
EUROMCONTACT is of the views that all devices covered by the Regulation 2017/745 should benefit from the possibility of electronic instructions for use, provided that:
i) for the use of a lay person, the first use typically follows a professional consultation addressing the safe and proper use of the device;
ii) for the use of a lay person, there is a continual use of the device;
iii) the device label or packaging includes the minimum warnings and/or precautions to be taken that need to be brought to the immediate attention of the lay user of the device;
iv) Other criteria already laid down in Regulation 207/2012 and included in the draft implementing Reg., such as a risk assessment (Art. 4) by manufacturer; providing paper instructions for use when requested and at no costs (Art. 5) be met.
Enclosed is the detailed contribution.
Read full response25 May 2020
EUROMCONTACT is the European Association representing the contact lens and lens care products manufacturers in the European Union.
Enclosed is the feedback from EUROMCONTACT on the proposed amendment of Annex XVII of REACH regarding CMRs.
Read full response