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英國脫歐
歐盟于2018年1月22日發布了一則題為”NOTICE TO STAKEHOLDERS--WITHDRAWAL OF THE UNITED KINGDOM AND EU RULES IN THE FIELD OF INDUSTRIAL PRODUCTS”的通知
【CE】劃重點：英國脫歐對醫療器械制造商的影響
歐盟于2018年1月22日發布了一則題為”NOTICE TO STAKEHOLDERS--WITHDRAWAL OF THE UNITED KINGDOM AND EU RULES IN THE FIELD OF INDUSTRIAL PRODUCTS”的通知，鄭重指出，從2019年3月30日00：00（退歐之日起），1）在英國設立的授權代表或負責人將不被視為歐盟的授權代表或負責人；2）英國的公告機構將不能根據歐盟法規執行符合性評估任務，也就說英國的公告機構將不能進行CE認證。以下是通知的全文，
NOTICE TO STAKEHOLDERS
WITHDRAWAL OF THE UNITED KINGDOM AND EU RULES IN THE FIELD OF INDUSTRIAL
PRODUCTS
The United Kingdom submitted on 29 March 2017 the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union. This means that, unless a ratified withdrawal agreement establishes another date, all Union primary and secondary law will cease to apply to the United Kingdom from 30 March 2019, 00:00h (CET) ('the withdrawal date'). The United Kingdom will then become a 'third country'.
Preparing for the withdrawal is not just a matter for EU and national authorities but also for private parties.
In view of the considerable uncertainties, in particular concerning the content of a possible withdrawal agreement, all interested parties, and especially economic operators, are reminded of legal repercussions, which need to be considered when the United Kingdom becomes a third country.
Subject to any transitional arrangement that may be contained in a possible
withdrawal,agreement, as of the withdrawal date, the EU rules in the field of non-food and
nonagricultural products, whether for use by consumers or professionals (hereinafter referred
to as "Union product legislation"), no longer apply to the United Kingdom. This has, in particular,
the consequences presented below for products placed on the EU-27 market6 as from the
withdrawal date. An indicative list of Union product legislation to which this notice applies can be
found in the annex. This notice should be read in conjunction with any complementary, more
specific notices on the legal consequences of the United Kingdom's withdrawal that may be
published with regard to any of the Union acts listed in the annex.
1. CONSEQUENCES FOR THE IDENTIFICATION OF ECONOMIC OPERATORS
According to Union product legislation, the importer is the economic operator established in the
Union who places a product from a third country on the Union market. As from the withdrawal
date, a manufacturer or importer established in the United Kingdom will no longer be considered
as an economic operator established in the Union. As a consequence, an economic operator
established in the EU-27 who, prior to the withdrawal date, was considered as an EU distributor
will become an importer for the purposes of Union product legislation in relation to products
from a third country that this economic operator places on the EU-27 market as from the
withdrawal date. This operator will have to comply with the specific obligations relevant to an importer, which are different from those of a distributor.
Currently, Union product legislation does not generally oblige the manufacturer to designate an authorised representative. However, if the manufacturer chooses to do so, the applicable legislation requires the authorised representative to be established in the Union. In addition, specific Union legislation does provide for the obligation to have an authorised representative (e.g. Union legislation on medical devices, transportable pressure equipment or marine equipment14) or a responsible person (cosmetic products) established in the Union.
Authorised representatives or responsible persons established in the United Kingdom will
not, as from the withdrawal date, be recognised as authorised representatives or
responsible persons for the purposes of the applicable Union product legislation.
Therefore, manufacturers are advised to take the necessary steps to ensure that, as from
the withdrawal date, their designated authorised representatives or responsible persons
are established in the EU-27. 自脫歐之日起，在英國設立的授權代表或負責人將不被承認為適用聯盟產品立法目的的授權代表或負責人。因此，制造商應采取必要的措施，以確保脫歐后，其指定的授權代表或負責人已在歐盟27國中設立。
2.CONSEQUENCES FOR CONFORMITY ASSESSMENT PROCEDURES AND NOTIFIED BODI
In some product areas, Union legislation requires the intervention of a qualified third party, known as Notified Body, in the conformity assessment procedure.
Union product legislation requires Notified Bodies to be established in a Member State and be designated by a Member State notifying authority for performing the conformity assessment tasks set out in the relevant act of Union product legislation. Therefore, as from the withdrawal date, UK Notified Bodies will lose their status as EU Notified Bodies and will be removed from the Commission's information system on notified organisations (NANDO database). As such, UK bodies will not be in a position to perform conformity assessment tasks pursuant to Union product legislation as from the withdrawal date.
從脫歐之日起，英國的公告機構將失去歐盟公告的地位并將在收到通知后從委員會的公告信息系統中刪除(NANDO database)。因此，從退出日起，英國公告機構將無法根據歐盟產品法規執行符合性評估任務。
When the applicable conformity assessment procedure requires or provides for the possibility of third party intervention, a certificate delivered by a body recognised as an EU Notified Body at the time of the placing of that product on the market will be required for products placed on the market as from the withdrawal date.
Economic operators are advised to take the necessary steps to ensure that, where the applicable conformity assessment procedures require the intervention of a Notified Body, they will hold certificates issued by an EU-27 Notified Body to demonstrate compliance for their products placed on the market as from the withdrawal date.當適用的合格評定程序需要公告機構的介入時，建議經濟運營商采取必要措施確保自脫歐之日起，其持有歐盟27國公告機構頒發的證書，以證明其投放市場產品合規性。
Where economic operators hold certificates issued by a UK Notified Body prior to the
withdrawal date and plan to continue placing the product concerned on the EU-27 market
as from the withdrawal date, they are advised to consider either applying for a new
certificate issued by an EU-27 Notified Body or arranging for a transfer – on the basis of
a contractual arrangement between the manufacturer, the UK Notified Body, and the EU-
27 Notified Body - of the file and the corresponding certificate from the UK Notified
Body to an EU-27 Notified Body, which would then take over the responsibility for that
certificate. This responsibility depends on the specific conformity assessment procedure
required for the product concerned under the applicable product legislation set out in
Annex.
經濟運營商已獲得英國公告機構頒發的證書，并打算在英國脫歐后仍然繼續將產品投放在歐盟市場, 建議他們考慮重新申請由歐盟27國公告機構頒布的新證或轉證——基于制造商,英國公告機構,和歐盟27國公告機構的合作協議，相關文件和相應的證書從英國公告機構轉到到歐盟27國公告機構，歐盟機構將接管該證書的責任。其責任視附件所適用的產品法規規定的相關產品的具體合格評定程序而定。
The websites of the Commission on the Single Market for Goods (http://ec.europa.eu/growth/single-market/goods_en and http://ec.europa.eu/growth/sectors_en) provide general information concerning Union harmonisation legislation applicable to non-food and non-agricultural products. These pages will be updated with further information, where necessary.
European Commission
Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs
歐盟于2018年1月22日發布了一則題為”NOTICE TO STAKEHOLDERS--WITHDRAWAL OF THE UNITED KINGDOM AND EU RULES IN THE FIELD OF INDUSTRIAL PRODUCTS”的通知，鄭重指出，從2019年3月30日00：00（退歐之日起），1）在英國設立的授權代表或負責人將不被視為歐盟的授權代表或負責人；2）英國的公告機構將不能根據歐盟法規執行符合性評估任務，也就說英國的公告機構將不能進行CE認證。以下是通知的全文，
NOTICE TO STAKEHOLDERS
WITHDRAWAL OF THE UNITED KINGDOM AND EU RULES IN THE FIELD OF INDUSTRIAL
PRODUCTS
The United Kingdom submitted on 29 March 2017 the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union. This means that, unless a ratified withdrawal agreement establishes another date, all Union primary and secondary law will cease to apply to the United Kingdom from 30 March 2019, 00:00h (CET) ('the withdrawal date'). The United Kingdom will then become a 'third country'.
Preparing for the withdrawal is not just a matter for EU and national authorities but also for private parties.
In view of the considerable uncertainties, in particular concerning the content of a possible withdrawal agreement, all interested parties, and especially economic operators, are reminded of legal repercussions, which need to be considered when the United Kingdom becomes a third country.
Subject to any transitional arrangement that may be contained in a possible
withdrawal,agreement, as of the withdrawal date, the EU rules in the field of non-food and
nonagricultural products, whether for use by consumers or professionals (hereinafter referred
to as "Union product legislation"), no longer apply to the United Kingdom. This has, in particular,
the consequences presented below for products placed on the EU-27 market6 as from the
withdrawal date. An indicative list of Union product legislation to which this notice applies can be
found in the annex. This notice should be read in conjunction with any complementary, more
specific notices on the legal consequences of the United Kingdom's withdrawal that may be
published with regard to any of the Union acts listed in the annex.
1. CONSEQUENCES FOR THE IDENTIFICATION OF ECONOMIC OPERATORS
According to Union product legislation, the importer is the economic operator established in the
Union who places a product from a third country on the Union market. As from the withdrawal
date, a manufacturer or importer established in the United Kingdom will no longer be considered
as an economic operator established in the Union. As a consequence, an economic operator
established in the EU-27 who, prior to the withdrawal date, was considered as an EU distributor
will become an importer for the purposes of Union product legislation in relation to products
from a third country that this economic operator places on the EU-27 market as from the
withdrawal date. This operator will have to comply with the specific obligations relevant to an importer, which are different from those of a distributor.
Currently, Union product legislation does not generally oblige the manufacturer to designate an authorised representative. However, if the manufacturer chooses to do so, the applicable legislation requires the authorised representative to be established in the Union. In addition, specific Union legislation does provide for the obligation to have an authorised representative (e.g. Union legislation on medical devices, transportable pressure equipment or marine equipment14) or a responsible person (cosmetic products) established in the Union.
Authorised representatives or responsible persons established in the United Kingdom will
not, as from the withdrawal date, be recognised as authorised representatives or
responsible persons for the purposes of the applicable Union product legislation.
Therefore, manufacturers are advised to take the necessary steps to ensure that, as from
the withdrawal date, their designated authorised representatives or responsible persons
are established in the EU-27. 自脫歐之日起，在英國設立的授權代表或負責人將不被承認為適用聯盟產品立法目的的授權代表或負責人。因此，制造商應采取必要的措施，以確保脫歐后，其指定的授權代表或負責人已在歐盟27國中設立。
2.CONSEQUENCES FOR CONFORMITY ASSESSMENT PROCEDURES AND NOTIFIED BODI
In some product areas, Union legislation requires the intervention of a qualified third party, known as Notified Body, in the conformity assessment procedure.
Union product legislation requires Notified Bodies to be established in a Member State and be designated by a Member State notifying authority for performing the conformity assessment tasks set out in the relevant act of Union product legislation. Therefore, as from the withdrawal date, UK Notified Bodies will lose their status as EU Notified Bodies and will be removed from the Commission's information system on notified organisations (NANDO database). As such, UK bodies will not be in a position to perform conformity assessment tasks pursuant to Union product legislation as from the withdrawal date.
從脫歐之日起，英國的公告機構將失去歐盟公告的地位并將在收到通知后從委員會的公告信息系統中刪除(NANDO database)。因此，從退出日起，英國公告機構將無法根據歐盟產品法規執行符合性評估任務。
When the applicable conformity assessment procedure requires or provides for the possibility of third party intervention, a certificate delivered by a body recognised as an EU Notified Body at the time of the placing of that product on the market will be required for products placed on the market as from the withdrawal date.
Economic operators are advised to take the necessary steps to ensure that, where the applicable conformity assessment procedures require the intervention of a Notified Body, they will hold certificates issued by an EU-27 Notified Body to demonstrate compliance for their products placed on the market as from the withdrawal date.當適用的合格評定程序需要公告機構的介入時，建議經濟運營商采取必要措施確保自脫歐之日起，其持有歐盟27國公告機構頒發的證書，以證明其投放市場產品合規性。
Where economic operators hold certificates issued by a UK Notified Body prior to the
withdrawal date and plan to continue placing the product concerned on the EU-27 market
as from the withdrawal date, they are advised to consider either applying for a new
certificate issued by an EU-27 Notified Body or arranging for a transfer – on the basis of
a contractual arrangement between the manufacturer, the UK Notified Body, and the EU-
27 Notified Body - of the file and the corresponding certificate from the UK Notified
Body to an EU-27 Notified Body, which would then take over the responsibility for that
certificate. This responsibility depends on the specific conformity assessment procedure
required for the product concerned under the applicable product legislation set out in
Annex.
經濟運營商已獲得英國公告機構頒發的證書，并打算在英國脫歐后仍然繼續將產品投放在歐盟市場, 建議他們考慮重新申請由歐盟27國公告機構頒布的新證或轉證——基于制造商,英國公告機構,和歐盟27國公告機構的合作協議，相關文件和相應的證書從英國公告機構轉到到歐盟27國公告機構，歐盟機構將接管該證書的責任。其責任視附件所適用的產品法規規定的相關產品的具體合格評定程序而定。
The websites of the Commission on the Single Market for Goods (http://ec.europa.eu/growth/single-market/goods_en and http://ec.europa.eu/growth/sectors_en) provide general information concerning Union harmonisation legislation applicable to non-food and non-agricultural products. These pages will be updated with further information, where necessary.
European Commission
Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs
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