Please note this is an extract of the original bulletin.
Corporate Sustainability Due Diligence Directive update
The Directive on corporate sustainability due diligence was nearing the adoption of the CS3D text by the end of 2023 through the agreement reached between the European Parliament and the Council. The rules were aimed at fostering sustainable and responsible corporate behaviour and to anchor human rights and environmental considerations in companies’ operations and corporate governance.
However, the dossier has been stopped at a very late stage, following Germany’s reversal. Subsequently, other Member States seem to have aligned with this dissent, as the vote of the European Council has been deferred due to concerns regarding the attainment of the requisite qualified majority for text adoption (55% of member nations representing 65% of the population). Presently, there is no set date for a rescheduled vote.
MedTech Europe issues trilogue recommendations on draft EU packaging rules
The EU institutions are busy finishing off the remaining EU Green Deal files under the remaining legislative term. This includes final negotiations (so-called trilogue negotiations)on a proposal for a new Packaging and Packaging Waste Regulation. MedTech Europe has issued its trialogue recommendations to EU decision-makers, including the Belgian Presidency, key Member States representations, lead MEPs, and the European Commission. At the core is our quest for final rules that properly consider the medical technology sectors’ specificities when introducing new sustainability criteria, notably on the recyclability of contact-sensitive packaging, and for securing a fully functional EU internal market.
MedTech Europe adopts paper ahead of a potential REACH Restriction dossier on PVC and its additives
MedTech Europe engaged in several European Chemicals Agency (ECHA) consultations on Polyvinyl Chloride (PVC), given its importance for medical technologies. On 22 November 2023, ECHA published its ‘Investigation Report’ which ultimately recommends that the European Commission grant ECHA a mandate to open a REACH (Regulation on the registration, evaluation, authorisation and restriction of chemicals) restriction dossier on PVC.
The Commission decision is expected in March 2024. MedTech Europe already adopted paper stating that should this Restriction be pursued, the industry would require derogations with sufficient transitional periods, as there are no alternatives, in addition to the need for ECHA to collect more data on e.g. the socio-economic impact of a ban, as this was not well substantiated in ECHA’s Report.
MedTech Europe publishes internal guidance on REACH microplastics restriction
Following the entry into force of the REACH (Regulation on the registration, evaluation, authorisation and restriction of chemicals) restriction on synthetic polymer microparticles (“microplastics”) on 17 October 2023, members of MedTechEurope have worked together to compile an internal document on the implementation of the restriction. While there is a general derogation for IVDs (conditional to certain information, reporting, and labelling requirements) and a six-years transitional period for MDs, there are several other derogations the medical technologies industry may benefit from.
The document outlines the various aspects of the restriction and supports members in their interpretation of the new requirements.
For more information on these documents members are requested to contact Regulatory@bivda.org.uk
