On October 29, 2024, EU MDCG (Medical Device Coordination Group) published guidance MDCG 2024-13 to provice clarity on the regulatory status of ethylene oxide (EtO) for the sterilization of medical devices.  EtO is used for sterilizing a variety of products, including medical devices, in vitro diagnostic medical devices (IVDs), and pharmaceuticals. The regulatory status of EtO for the sterilizat..

On November 11, 2024, the European Medical Device Coordination Group (MDCG) issued an update to the Questions and Answers on vigilance MDCG 2023-3, which includes a comprehensive update concerning the scope of in vitro diagnostic medical devices (IVDs) regulated under the IVDR 2017/746.  The revised guidelines of MDCG 2023-3, which include the IVDR, cover the following content.:  (1) The definit..

On September 20, 2024, the European Commission (EC) updated Regulation (EU) 2024/2462 concerning perfluorohexanoic acid (PFHxA), its salts, and related substances.  Since 2019, Germany has proposed concentration limits for PFHxA. PFHxA is a substance used across various industries and is highly persistent, posing unacceptable risks to health and the environment. As a result, the regulation on th..

On October 30, 2024, a Q&A was published regarding a gradual roll-out of Eudamed, to obligation to inform in case of interruption or discontinuation of supply, and the transitional provisions for certain in vitro diagnostic medical devices, in connection with Article 10a inserted in (EU) 2024/1860 (amended on June 30, 2024). This Q&A concerns the obligation to notify the discontinuation or inter..

On October 8, 2024, the European Commission’s Medical Device Coordination Group (MDCG) announced guidance MDCG 2024-11 regarding the qualification of in vitro diagnostic medical devices (IVDs). To achieve qualification as an IVD or an accessory, a product must meet the criteria defined in Article 2(2) or Article 2(4) of the IVDR. The MDCG 2024-11 guidance clarifies the scope of products covered ..

The European Medical Device Management System has been upgraded from Directive MDD(Directive 93/42/EEC for Medical device) to Regulation MDR(Medical Device Regulation (EU) 2017/745). With the introduction of higher regulation MDR, Companies that have undertaken the work of certification bodies with existing MDD NBs should be re-evaluated by enhanced European authorities on NBs' designation crite..

The European Medical Device Regulations (Regulation 2017/745, MDR) require that each particular device model has its own UDI-DI. Contact lenses vary widely, requiring the manufacturer to specify a number of UDI-DI. The EC adopted this mandate out of concern that a higher number of UDI-DI would lead to a surge in medical device registrations in EUDAMED. The amendment takes effect on November 9, 2..

In the EU, cosmetic manufacturers and suppliers who want to sell cosmetics must comply with the requirements. Here are the following legal requirements for selling cosmetics in the EU market and the regulations on consumer safety protection and environmental responsibility. Labeling Requirements The EU's cosmetic packaging should contain key information such as product name, ingredient, content,..

It has obligations such as record keeping, reporting and handling of products through the following four corporations designated as Economic Operators under the European Medical Device Regulations (EU MDR). Manufacturers Importers Distributors Authorized representatives However, manufacturers that are not located in the EU require authorized representatives. As such, MDCG 2019-5 rev.1 outlines t..

欧州議会は医療機器規定（MDR）と体外診断用医療機器規定（IVDR）転換日程の延長に対する修正案に賛成しました。 改定案は欧州連合官報であるUJEUに掲載される日に発行されますが、欧州理事会で改定案をまだ採択できてないとのことです。 ＜改定案の主要規定日程＞ Legacy Class III and Class IIb implantable devices : 2027年 12月 Legacy Class IIa and Class I devices : 2028年 12月 Class III implantable custom devices : 2026年 5月 Official Journal of the European Union (OJEU)の修正案が最終的に発表される前に、CEマーク認証書が満了になるよう設定された製造業者は、新しい規程の遵守締切日が公式発表される..