The Weekly Pulse: 13th March – 17th March
What’s HOT in our Regulatory World
What are our clients looking at?
This week’s trending sources in C2P
- IATA: Lithium Battery Guidance Document, 2023
- Massachusetts (USA): Prohibition of PFAS in Food Packaging and Certain Consumer Products, House Bill 2197, 2023
- UK: UKCA marking – Roles and Responsibilities, Guidance Document, August 2022
What is our Content Team talking about?
Electronics, Apparel, and Textiles from Malaysia, Vietnam, Thailand, and Sri Lanka are also subject to review under the Uyghur Forced Labor Prevention Act – Joanne O’Donnell
On March 14th, the U.S. Customs and Border Protection (CBP) released a statistics dashboard tracking their enforcement of the Uyghur Forced Labor Prevention Act (UFLPA) for the period 21 June 2022 to 3 March 2023.
The CBP also released a Data Dictionary to assist in reviewing the metrics on the dashboard. Some data that is worth noting:
- A total of 3,237 shipments, valued at US$961 million, were stopped and subjected to UFLPA reviews or enforcement actions by the CBP during this period.
- 424 shipments were denied entry whilst 1,090 shipments were subsequently released onto the US market. The remaining shipments are pending review.
- The top 3 industries impacted by the CBP’s enforcement actions are:
-Apparel, Footwear, and Textiles; and
-Industrial and Manufacturing Materials
- China was not the only country of origin for products stopped by the CBP during this period. Imports from Malaysia, Vietnam, Thailand, and Sri Lanka were also impacted.
What are our Knowledge Partners talking about?
The Council of the European Union votes in favor of amending the transitional provisions in the MDR and IVDR – Cooley
On 7 March 2023, the Council of the EU (“Council”) approved at first reading the European Commission’s proposal, supported by the European Parliament, to amend the transitional provisions in Regulation (EU) 2017/745 on medical devices (“MDR”) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (“IVDR”). All 27 members of the Council, representing the 27 EU Member States, voted in favor of the proposed legislative amendment during a session of the Education, Youth, Culture, and Sports Council.
As discussed in our previous blog post, the related amendment was proposed by the European Commission in response to the imminent risk of medical device shortages on the EU market resulting from the limited capacity and availability of notified bodies and the insufficient preparedness of device manufacturers to bring their devices into conformity with the Regulations within the original transition timelines. The amendment will not introduce any substantive revisions to the requirements established in the Regulations. It will, however, postpone the timeline within which manufacturers of certain medical devices certified in accordance with Directive 93/42/EEC on medical devices (“MDD”) and Directive 90/385/EEC on active implantable devices (“AIMDD”) will be required to comply with the requirements established in the MDR.
The extension of the transitional periods in the MDR will follow a staggered approach based on the risk classification of each device and will be subject to cumulative conditions. These conditions are intended to ensure that only devices that are safe and for which the necessary actions have been taken to facilitate their transition to the requirements established in the MDR benefit from this extension.
Specifically, the legislative amendment will allow certain medical devices that are certified in accordance with the MDD and the AIMDD prior to 26 May 2021 – so-called “legacy” devices – to be placed on the EU market or put into service until:
- 31 December 2027 for Class III and Class IIb implantable devices;
- 31 December 2028 for Class IIb, Class IIa, and Class I devices placed on the market in sterile condition or having a measuring function; and
- 26 May 2026 for Class III custom-made implantable devices provided that an application for conformity assessment has been lodged before or on 26 May 2024 and a written agreement has been signed by the notified body and the manufacturer before or on 26 September 2024.
The validity of the CE Certificates of Conformity for legacy devices benefitting from one of the above transitional periods will also be prolonged based on the risk class of each device.
The legislative amendment will also allow medical devices and IVDs covered by a CE Certificate of Conformity issued in accordance with the MDD, AIMDD, or Directive 98/73/EC on in vitro diagnostic medical devices (“IVDD”) before 26 May 2021 to continue to be sold on the EU market. Removing the “sell-off” deadline in the MDR and the IVDR will prevent safe medical devices that have already been placed on the EU market but have not yet reached the final user from being withdrawn.
The medical device industry has welcomed the adoption of the extended transitional periods by the European Parliament and Council and the removal of the “sell-off” deadline. Med Tech Europe, the trade association representing the EU medical device industry, has called for an “aligned and clear interpretation of the amendment”. This includes a streamlined submission process for conformity assessment by notified bodies and guidance on the type of evidence needed to demonstrate that the validity of CE Certificates of Conformity has been extended.
Formal adoption of the European Commission proposal by the European Parliament and the Council will take place on 15 March 2023 with the signature of the legislative act by the Presidents of the two bodies. The amended Regulation will then enter into force on the day of its publication in the Official Journal of the European Union.
What are our clients asking about?
” Does this Singapore legislation (Singapore: Resource Sustainability (in-store collection of e-waste) Regulations No. S 424/2021 ) impact EEE or components not regarded as e-waste?”
Answer by Michelle Walsh
The scope of Singapore Regulations No. S 424/2021 is as follows:
(a) the regulated consumer products mentioned in items 1 to 9 of the First Schedule to the Resource Sustainability (Prescribed Regulated Products) Regulations 2019 are as follows:
- A printer with a weight of 20 kg or less
- A consumer computer
- A desktop monitor
- A mobile telephone
- A router that is not a specified router
- A modem
- A set‑top box
- An EMC Class B network switch
- A network hub with 8 or fewer ports
(b) a portable battery;
“portable battery” means a battery that —
- is sealed;
- is not designed for compatibility with specific products only; and
- can be hand‑carried,
but does not include an industrial battery or a battery that is a component of another product and not designed to be removable by the end user;
(c) a consumer lamp;
“consumer lamp” means a specified single‑phase lamp that is —
- an incandescent lamp with an Edison screw or a bayonet lamp cap, of 25W or above but not exceeding 100W
- a compact fluorescent lamp with integrated ballast, with an Edison screw or a bayonet lamp cap, of up to 80W;
- a compact fluorescent lamp without integrated ballast, with a G24d lamp cap, of up to 80W;
- a linear, double-capped, fluorescent lamp with a tube diameter of 16 mm (T5) or 26 mm (T8) and with a length of 0.5 m and above but not exceeding 1.5 m, of up to 80W;
- a circular fluorescent lamp with a tube diameter of 16 mm (T5) or 29 mm (T9) and with a lamp diameter of 8 inches and above but not exceeding 16 inches, of up to 80W;
- an LED lamp, with an Edison screw or a bayonet lamp cap, of up to 80W; or
- an LED lamp designed as a direct replacement for a lamp described in paragraph (c) or (d) without requiring any internal modification of the luminaires, of up to 80W;
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This information is based on the most viewed regulations on C2P this month.
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