Certification Trends

Certification Trends

January 10, 2019. Brexit

Influence of Brexit on European Certification of Cosmetics and medical Devices.

Medical Devices

  • 1. Brexit stutus (UK & Northern Ireland)
    • A) Date of effect: Mar. 29, 2019
    • B) Current status
      • ① November 14, 2018. UK and Northern Ireland drew up implementation agreement document with European Union.
      • ② Though the brexit is effective on March 29, 2019, the CE certificates issued by UK notified boeis will reain valid until December 31, 2020.
      • ③ It is unclear what will happen after December 31, 2010, as a new consensus on the relationship between EU and the UK will be made.
      • ④ It is anticipated that the certification will be transferred to notified bodies outside of UK during implementation period.
      • ⑤ The draft implementation agreement document is a draft agreement, which has been accepted by UK government. However, it is not officially announced yet.

Source: https://ec.europa.eu/commission/publications/draft-agreement-withdrawal-united-kingdom-great-britain-and-northern-ireland-european-union-and-european-atomic-energy-community-agreed-negotiators-level-14-november-2018_en


Current status: From March 30, 2019, the UK is no longer an EU member. Hence, a company with UK based RP should appoint an EU based RP.

How to prepare: WiseCompany Inc., is providng a RP service based on Ireland and Slovenia. Our customers will have no impact on their regulatory status from Brexit.

In additiaon, we are preparing UK based RP if UK requires to appoint a RP in UK.

January 5, 2017. Medical device(hereinafter, CE MDD) certification in European counties is getting more and more difficult since 2013.

  • Clinical evaluation guideline is revised to revision 4
  • Medical device regulation is about to be come effective

U.S. market is also unstable and has possibility to increase import barriers.

China is now looking inside to protect their domestic industries.
China is alredy closing their market for foreign companies in medical devices, cosmetics, electronics, and cultural industries.

Changes of certification and approval requirements of E.U. and U.S. has possibility to influence other countries because most of the coutries have adapted either European or U.S. system into their own.