英国脱欧后，输英产品如何认证？还认CE吗？现有的CE怎么办？

amo

           继英国公投脱欧结果，英国政府协商条款结果前，将有一个过渡期。在这情况下，BSI目前担任欧盟一份子重要岗位，如下三个方面声明：

          1.  BSI 作为英国国家标准机构的角色：

         作为英国国家标准机构，BSI将继续制定并公布的英国标准。BSI不会影响到两个国际标准化组织ISO和IEC的成员资格，BSI将继续发挥一个有影响力的领导作用。欧洲有三个标准化组织 - CEN，CENELEC和ETSI。BSI的CEN和CENELEC的正式会员将继续，而英国政府脱欧后会做妥善的安排。在这个过渡时期，BSI将与英国政府合作 (如商业，创新和技能部) 和其他各方在适当如欧洲的政治体制和欧洲标准化组织就其在欧洲标准化体系的发展中的作用。我们预计BSI的ETSI成员将不受影响。我们将持续向您定期更新为政治形势的发展和讨论中取得进展。现在，它一如往常，最重要的是，我们想向你们保证，BSI将继续帮助这已有115年历史的组织。

          2.  BSI 扮演欧盟公告机构产品认证的角色：

          英国脱欧后，政府安排BSI作为欧盟公告机构的角色不会改变。我们确认，产品已经认证将继续被欧盟当局和各成员国所接受。在这段过渡期内，BSI将与英国政府紧密合作(如商业，创新和技能部) 和UKAS (英国认证机构)，使BSI继续被认可为指定机构。我们将持续向您定期更新为政治形势的发展和讨论中取得进展。现在，它一如往常，最重要的是，我们想向你们保证，BSI将继续帮助这已有115年历史的组织。

       3. BSI 作为欧盟医疗产品认证机构的角色：

         英国脱欧后，政府安排BSI作为欧盟公告机构的角色不会改变。在这段过渡期内，BSI将与药品和健康产品管理局 (MHRA) 密切合作，以使BSI继续被认可为医疗产品的指定机构。BSI充分预期，我们仍将是一个长期的欧盟主要医疗设备认证机构，因为在地方建立公认的现有机制，非欧盟国家参加欧盟作为认证机构。例如：在挪威的指定机构 (EEA)，瑞士和澳大利亚 (通过互认协议) 被认为是欧盟相关立法的目的，认证机构。我们将继续向您更新定期为政治形势的发展和讨论中取得进展。现在，它是一如往常，最重要的是，我们想向你们保证，BSI将继续为欧盟医疗产品市场准入做努力，正如当年我们帮忙完成三个欧盟医疗指令的设立。

　　所有的管理系统的培训和认证仍然持续，不受公投结果的影响。

原文件如下：


BSI statement

Following the result of the UK referendum to leave the EU there will be a transition period while the UK Government negotiates the terms as a result of the referendum. There are three areas where BSI currently holds important positions as part of the EU and these are as follows:

1.   BSI’s role as the National Standards Body

As the UK’s National Standards Body, BSI will continue to develop and publish British Standards. Our membership of the two international standardization organizations, ISO and IEC, will not be affected where we will continue to play an influential leadership role.

There are three European Standardization Organizations - CEN, CENELEC and ETSI. Our full membership of CEN and CENELEC will continue while the UK Government sets out the arrangements for its withdrawal from the EU. During this transition period, BSI will be working with the UK Government (such as Department of Business, Innovation and Skills) and other parties as appropriate such as European political institutions and European Standardization Organizations regarding its role in the development of the European standardization system. We expect BSI’s membership of ETSI will be unaffected

We will continue to keep you updated on a regular basis as the political situation develops and discussions progress.  For now, it’s business as usual and most importantly, we would like to assure you that BSI will continue to help organizations as we have done for the past 115 years.

2.   BSI’s role as an EU Notified Body for Product Certification

BSI’s role as an EU Notified Body will not change while UK Government sets out the arrangements for its withdrawal from the EU. We anticipate that products already certified and those certified while the negotiations progress, will continue to be accepted by the EU authorities and member states of the EU. During this transition period, BSI will be working closely with the UK Government (such as Department of Business, Innovation and Skills) and UKAS (UK Accreditation Service) to enable BSI to continue being recognized as a Notified Body.  

BSI further anticipates it will remain an EU Notified Body for assessing and approving products against the relevant CE directives and regulations (e.g.  Construction Product Regulation, PPE Directive and the Gas Appliance Directive).  There are recognized existing mechanisms in place for non-EU countries to participate, these include the Mutual Recognition Agreements between the EU and America, Canada, Australia, Switzerland and Japan.  Regulatory authorities in these countries designate Notified Bodies to carry out these activities in the same way as member states of the EU.   

We will continue to keep you updated on a regular basis as the political situation develops and discussions progress.  For now, it’s business as usual and most importantly, we would like to assure you that BSI will continue to help organizations as we have done for the past 115 years.

3.   BSI’s role as an EU Medical Devices Notified Body

BSI’s role as an EU Notified Body will not change following the recent decision of the EU referendum while the UK Government sets out the arrangements for its withdrawal from the EU. During this transition period, BSI will be working closely with the Medicines and Healthcare products Regulatory Agency (MHRA) to enable BSI to continue being recognized as a Notified Body for Medical Devices.

BSI fully anticipates we will remain a long term major EU Medical Device Notified Body as there are established well recognized existing mechanisms in place for non-EU countries to participate as EU Notified Bodies.  For example, the designated organizations in Norway (under EEA recognition), Switzerland and Australia (through Mutual Recognition Agreements) are recognized as Notified Bodies for the purposes of the relevant EU legislation.

We will continue to keep you updated on a regular basis as the political situation develops and discussions progress.  For now, it’s business as usual and most importantly, we would like to assure you that BSI will continue to provide EU market access as we have done since the inception of the three EU Medical Device Directives.

All management systems training and accredited certification remains unaffected by the outcome of the referendum.

amo

测试回复测试回复测试回复测试回复测试回复