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The European Commission has published on its website the "Single Market Emergency Instrument (SMEI) " initiative, which aims to inform the public and stakeholders about the Commission's future legislative work, so that they can provide feedback on the Commission's understanding of the problem and possible solutions, and provide any relevant information they may have, including the potential impacts of the different options.

The initiative is part of the Commission's 2022 Work Programme, which addresses fragmentation, barriers and vulnerabilities of the Single Market in emergency situations EU Health Emergency Preparedness and Response Authority (HERA) (europa.eu) a The Commission proposes a new directive to enhance the resilience of critical entities providing essential services in the EU (europa.eu). In the wake of the COVID-19 pandemic and the Russian invasion of Ukraine, there is a need to build a stronger economic base that is more resilient, competitive, fit for green and digital transitions and built on the strengths of the Single Market. The initiative will be a general tool for Single Market emergencies.

While the overall legal framework of the Single Market is considered sound, the following problems could limit the European Union's ability to respond to any major crisis with significant cross-border implications that could significantly impede the free movement of people, goods and services in the Single Market and/or disrupt supply chains:

  1. lack of information, coordination and communication channels
  2. the lack of legal arrangements or measures for emergency and crisis management and guidance on how to apply them.

The aim of the initiative is therefore to prevent, prepare for and respond to disruptions:

  1. providing appropriate information, coordination and communication mechanisms between the EU institutions, Member States and stakeholders, adapted to the different phases of the crisis
  2. providing the means to ensure the resilience of products and services relevant to a particular type of crisis, and guaranteeing the greatest possible freedom of movement of goods, services and people in times of crisis.

The "Crisis Preparedness" pillar, if included, would aim to prevent strategic disruptions and prepare for crises before they occur.

Likely impacts "The measure" would help improve the crisis management of the Single Market and its smooth functioning in times of crisis.

An "Impact Assessment" will be prepared to identify the issues, identify policy options and assess the likely positive and negative impacts arising from the different options.

The consultation strategy is intended to gather evidence and views from a wide range of stakeholders and give them the opportunity to provide relevant information on the problems and possible solutions to the distortions of the single market resulting from the crisis.

The initiative is open to national authorities responsible for the Single Market, NGOs representing civil society, national consumer associations, associations representing industry, business and professionals, businesses, including SMEs, social partners, academic experts on free movement in the Single Market and citizens.

The call for evidence, including the public consultation, can be found at New EU instrument to ensure the functioning of the single market during emergencies (europa.eu) on the Commission's official website for public consultations. The public consultation closes on 11 May 2022.

The European Commission services have made available a survey for European companies and stakeholders on the disruption of supply chains in the current geopolitical environment. The survey is currently open for participation until 25 April 2022 and is available here: EUSurvey - Survey (europa.eu)

In the context of the revision of the Toy Safety Directive 2009/48/EC, a related public consultation was published on the European Commission's Better Regulation Portal on 2 March 2022 for a 12-week feedback period:
Protecting children from dangerous toys and strengthening the single market in the sector - revision of the Toy Safety Directive (europa.eu)

The public consultation is open to contributions from all interested parties. Contributions are welcome from citizens, producers, importers, distributors and other businesses, including SMEs, consumer and industry associations, conformity assessment bodies, NGOs and Member State authorities, including market surveillance and customs authorities.

The public consultation is open for contributions from all interested parties to 25 May 2022.

A reference to other EN standards harmonised to the MDR and IVDR has been published in the Official Journal of the EU.

The list of standards can be found in the annexes to the Commission Implementing Decisions under the following links:

Commission Implementing Decision (EU) 2022/6 of 4 January 2022 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for biological evaluation of medical devices, sterilisation of healthcare products, aseptic processing of healthcare products, quality management systems, marks to be used with information provided by the manufacturer, processing of healthcare products and home light therapy devices

Commission Implementing Decision (EU) 2022/15 of 6 January 2022 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for the sterilisation of healthcare products, aseptic processing of healthcare products, quality management systems, marks to be used with information provided by the manufacturer and requirements for establishing the metrological continuity of values assigned to calibrators, truth control materials and human samples

On 28 January 2022, Regulation (EU) 2022/112 of the European Parliament and of the Council amending Regulation (EU) 2017/746concerning transitional provisions for certain in vitro diagnostic medical devices and the deferral of the conditions of applicability for devices manufactured and used within medical establishments.

The change concerns:

Details can be found under the following link:

Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022 amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferral of conditions of application for devices manufactured and used within medical devices

EUROLAB Annual Report 2021

EUROLAB is pleased to announce the publication of the Annual Report 2021. This Annual Report includes an overview of EUROLAB's most notable achievements and landmark events for 2021, with details on the current and future activities, international collaborations, projects of interest to laboratories and the latest news from the Technical Committee on Quality Assurance.

The document summarizes EUROLAB's involvement in the laboratory community and the cooperation with its stakeholders. We hope this report would bring you more insights regarding our activities and a thorough understanding of our organisation.

Find the complete report here.

On 1 January 2022, Government Regulation No. 499/2021 Coll.amending Government Regulation No. 426/2016 Coll., on conformity assessment of radio equipment when supplied to the market.

The change concerns:

Annex 1, point 3, including footnotes 9 and 11.

Transpositions in the field of railway interoperability
On 30 November 2021, Act No. 426/2021 Coll., amending Act No. 266/1994 Coll., on Railways, as amended, and Act No. 634/2004 Coll., on Administrative Fees, as amended, was published in the Collection of Laws of the Czech Republic in Part 191.
The Act transposes, inter alia, Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 on the interoperability of the rail system in the European Union.

Evaluation of the New Legislative Framework (NLF, New Legislative Framework) focuses on five main criteria -
1. efficiency,
Efficiency 2,
3. the relevance of technological development,
4. coherence and
5. EU added value.

The evaluation is not concerned with the issue of harmonised standards and market surveillance. The target group for the evaluation consists mainly of economic operators, industry associations, national authorities responsible for implementing product legislation, notifying authorities, notified bodies, market surveillance authorities (MSAs), standardisation organisations and consumer associations. The questionnaire is available at Targeted consultation on certain aspects of the New Legislative (chkmkt.com) and can be completed no later than
21. 1. 2022.

On 18 October 2021, the European Commission launched public consultation to the initiative "Civil liability - adapting liability rules to the digital age and artificial intelligence".

Public consultation with focuses on two areas related to liability for damage caused by artificial intelligence:

- Section I concerns product liability directive (Directive 85/374/EEC), which establishes the liability of manufacturers (and hence importers) for damage caused by product defects. In this respect, the public consultation follows the assessment of the Directive carried out in 2018 to determine whether the rules contained in the Directive are optimal and whether they require revision in relation to new technologies.

- Section II focuses on and other liability regimes and their effectiveness in relation to the damage that may arise in relation to the use of artificial intelligence. Questions are directed, for example, at the harmonisation of the objective liability of the operator or user, mandatory liability insurance, the extent of the damages to be paid or the burden of proof.

It is possible to answer both sections or only Section I. It is not possible to answer only Section II. The public consultation runs until 10 January 2022.

Internet address: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12979-Obcanskopravni-odpovednost-prizpusobeni-pravidel-odpovednosti-digitalnimu-veku-a-umele-inteligenci_cs

A new Commission Recommendation (EU) 2021/1433 on conformity assessment and market surveillance procedures in relation to the COVID-19 threat has been published in the Official Journal of the EU, which will phase out Commission Recommendation (EU) 2020/403.

The full announcement can be found at here (available in Czech language only).

The Toy Safety Directive sets out the safety requirements that toys must meet if they are to be placed on the EU market.
On 5 October 2021, the European Commission published background information on the revision of the Toy Safety Directive (2009/48/EC) and a timetable. You can send feedback on this call for information. Your input will be taken into account in the further work on this initiative. The aim of this initiative is to better protect children from the risks that may be associated with toys, in particular from the chemicals they contain. The initiative builds on the strategy for the sustainability of chemicals and on the evaluation of existing toy safety rules completed in 2020. It also aims to strengthen the single market for toys.
The call is open until 2 November 2021 and is published on the Commission's website: Protecting children from dangerous toys and strengthening the single market in the sector - revision of the Toy Safety Directive (europa.eu)

The UK government has taken the decision to allow the import of CE marked goods into the UK market until 1 January 2023.
https://www.ukas.com/resources/latest-news/ce-mark-acceptance-extended-to-2023/

Although the UK Government has made considerable efforts to support industry and trade in the transition to the new UKCA regime, the pandemic situation has impaired the ability of firms to fully adapt, hence the announced extension of the ability to import CE marked goods. This means that all product lines can fully prepare for the use of the UKCA from 1 January 2023. This is now the latest deadline and will no longer be extended. A full list of all product lines covered by the UKCA marking can be found at
https://www.gov.uk/guidance/using-the-ukca-marking#:~:text=the%20European%20Union-,More%20information,civil%20explosives,-Legislative%20areas%20where.

Over the next 16 months, the UK Government will continue to actively support the industry in preparing for the new requirements. The next such event will be a webinar entitled Manufactured goods regulation - placing goods on the market in GB and NI, where the UK Department for Business, Energy and Industrial Strategy (BEIS) will educate businesses on the changes that will take place and the steps that need to be taken.
Invitation: https://www.eventbrite.co.uk/e/beis-webinar-the-ukca-mark-the-new-domestic-regime-tickets-167053460397

The Department of State Testing of the Ministry of Industry and Trade informs that ČSN EN 206+A1 of 04/2018, cancelled as of 08/2021, is intended as another technical document related to Government Regulation No. 163/2002 Coll., as amended. Until the publication of the Czech translation of ČSN EN 206+A1 in the Bulletin of the Ministry of Industry and Trade, the technical requirements for concrete set out in Regulation 163/2002 Coll. can be met by using this cancelled ČSN EN 206+A1. Subsequently, both versions (+A1 and +A2) will serve as designated concurrently for a transitional period of 12 months.

Communication of the State Testing Department of the Ministry of Industry and Trade

Centrum stavebního inženýrství a. s., Pražská 16, 102 00 Praha 10, ID No. 45274860 ceased its activities on 30 March 2021 notified body No 1390 in the conformity assessment of products under Regulation (EU) No 305/2011 of the European Parliament and of the Council laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC. All activities of Notified Body No 1390 have been transferred to notified body No 1023 - Institute for Testing and Certification, a. s., třída Tomáše Bati 299, Louky, 763 02 Zlín, ID No. 47910381, within the framework of which the Division Civil Engineering Centre. Customers can find further information including contact details on the website http://www.csias.cz a http://www.itczlin.cz

The archive of Notified Body Notifications No 1390 in the EU information system "NANDO" can be consulted at the following link:

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notifiedbody.notifiedbody&refe_cd=EPOS%5F54733&filter=DNB

Standardisation Strategy Plan

European Standardisation System (ESS) has been successful in recent decades, is a cornerstone of today's single market and supports the overall competitiveness of EU industry. In an ever-changing environment, the European Standardisation System is a flexible and effective way to ensure that European and international standards are set in line with the EU's strategic interests and values.

But the ESS is currently not sufficiently equipped to anticipate the necessary future standards, especially if it is to support the EU's objectives under the Green Deal for Europe and the European Digital Decade.

The initiative aims to consolidate and improve the EU standardisation system so as to continue to promote a well-functioning single market, foster the competitiveness of EU industry and protect EU citizens and the environment.

The European Commission is asking for feedback from citizens and stakeholders, especially on the questions:

  1. Does the current European standardisation system support European strategic interests?
  2. How can the EU promote global leadership in setting standards?
  3. Are changes in leadership and working methods needed to improve the implementation of the European Standardisation System?

The main stakeholders in the consultation are EU industry, consumer organisations, universities, trade associations, SMEs, Member States, European/national parliaments, European/national standardisation bodies. The Commission will conduct some targeted consultations to ensure that all key stakeholders have the opportunity to express their views.

More detailed information can be found at the link: roadmap.

Proposal for a new European regulation on machinery products
On 26 April 2021, the Council of the EU launched discussion of the proposal for a new European regulation on machinery products (Machinery Products Regulation).  Under the leadership of the Portuguese Presidency, the meetings will continue at fortnightly intervals, with a total of five online meetings scheduled until the end of June 2021. It is provisionally expected that the draft deliberations may take between one and two years.

Like major changes the proposal contains? These are mainly the following amendments and additions.

Form of legislation
The proposal takes the form of a European regulation. The choice of a Regulation will allow for a faster and more coherent application of the proposed legislation and will create a clear regulatory environment for economic operators.

Scope and definitions
The scope of the Regulation in terms of the scope of machinery remains the same, but the subject matter in Article 1 is added by adding a new bullet point to the definition of machinery, the definition of safety component is extended to include software and a definition of substantial modification is added.

Exclusion
The exclusion has been extended to all means of transport moving on roads. As regards the exclusion from the list of electrical and electronic products under the Low Voltage Devices Directive (LVD), it has been extended to LVD products with Wi-Fi.

High-risk machines
The proposal lays down rules for the classification of high-risk machinery currently listed in Annex IV of Directive 2006/42/EC.

Obligations of economic operators
The proposal brings the obligations of manufacturers, authorised representatives, importers and distributors into line with Decision NLF 768/2008/EC.

Presumption of conformity of machinery
The presumption of conformity for the use of harmonised standards or parts thereof published in the Official Journal of the EU remains.

Conformity assessment
The proposal retains internal production control for machinery not classified as high risk. For high-risk machinery, it accepts only conformity assessment with the involvement of an independent third party.

Notified entities
In line with Decision NLF 768/2008/EC, the proposal sets out the requirements for conformity assessment bodies as well as for the national authorities responsible for these bodies.

Proposal a new European regulation on machinery products has been published together with a proposal for a regulation on artificial intelligence (Artificial Intelligence Regulation) as part of a package of AI initiatives. The two proposals are interlinked.

The text of both proposals, including the impact assessment, can be found at:

https://ec.europa.eu/commission/presscorner/detail/en/ip_21_1682

 

EU Product Safety Award

The EU Product Safety Award is given to companies that make an outstanding effort to protect consumers. They make safety a priority and not only comply with EU regulations, but go beyond them.

In 2021, the prize will be awarded in two categories: protecting the safety of vulnerable consumer groups a articulation security and new technologies.

Safety is of paramount importance to consumers. If you too are striving for it, then this competition could make your business highly visible!

For more information, please visit the website at https://ec.europa.eu/safety-gate/#/screen/pages/safetyAward

Last year, the European Commission launched an open public consultation on the evaluation of the Electromagnetic Compatibility Directive, building on its predecessor, the targeted one, and unlike the targeted one, the open consultation also involves the general public. Please submit your completed questionnaire - see link below - by 29 January 2021.
https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/11868-Evaluation-of-the-Electromagnetic-Compatibility-Directive/public-consultation

At the web address https://europa.eu/youreurope/#cs The Your Europe portal was launched on 12 December 2020, based on Regulation (EU) 2018/1724 of the European Parliament and of the Council establishing a single digital gateway for providing access to information, procedures, assistance and problem-solving services and amending Regulation (EU) No 1024/2012.

The portal is intended to become a pan-European signpost to a wide range of information shared at EU and national level with EU citizens on topics such as business, travel, transport, etc. This is the first phase, with a second phase to be launched in 2023, when the portal will concentrate access to online procedures that can be used by citizens across the EU.

The European Commission has launched a public consultation on the evaluation of the New Legislative Framework, excluding market surveillance. Comments can be submitted until 2. 12. 2020

https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12654-Evaluation-of-the-New-Legislative-Framework-for-EU-legislation-on-industrial-products

The European Commission has launched a public consultation on the revision of the European Ecodesign Directive. The public consultation, open until 2 November 2020, can be accessed via this link:
https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12567-Sustainable-Products-Initiative

The Department of State Testing of the Ministry of Industry and Trade informs all stakeholders in the field of construction products that they can take part in a pan-European public consultation, aimed at revising the CPR. The consultation is open until 25 December 2020 on the European Commission's website at the following link:
https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12458-Review-of-the-Construction-Products-Regulation

Information on SHZ and fire extinguishers

The EC's Communication on preparing for the end of the transition period between the EU and the UK under the UK's withdrawal agreement, which runs until the end of this year only, published by the EC on 9 July 2020, and other documents can be found here:

https://ec.europa.eu/info/european-union-and-united-kingdom-forging-new-partnership/future-partnership/getting-ready-end-transition-period_en

The Department of State Testing of the Ministry of Industry and Trade informs all stakeholders in the field of construction products that they can participate in a pan-European open online survey called Future Options for the Review of the Construction Products Regulation (CPR). The survey is open until 31 August 2020 on the European Commission website under this link:
https://ec.europa.eu/eusurvey/runner/FutureOptionsForTheReviewOfTheCPR

The European Commission is also inviting all stakeholders to participate in an online discussion on the present and future of Regulation (EU) No 305/2011 of the European Parliament and of the Council laying down harmonised conditions for the marketing of construction products (CPR). The Q&A will take place on three dates, 22 June, 6 July and 20 July 2020. Interested parties can register under this link:
https://ec.europa.eu/eusurvey/runner/QandAsessionCPRReviewJuneJuly2020

On 19 May 2020, Commission Implementing Regulation (EU) No 2020/666 of 18 May 2020 amending Implementing Regulation (EU) No 920/2013 as regards the extension of the validity of the designation, supervision and monitoring of notified bodies was published in the Official Journal of the European Union (L 156).

These are follow-up measures to ensure the smooth functioning of certification of medical devices in the context of the postponement of the application of Regulation (EU) No 2017/745 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1590754867991&uri=CELEX:32020R0666