Our regulatory subject matter experts help a range of stakeholders solve compelling regulatory challenges associated with supply chain data management. We compile these insights to help educate compliance professionals through content, webinars and events. They also provide advice to Assent clients. Here are the top five questions our Regulatory team has responded to over the past month.

Question: Are contract manufacturers — companies that manufacture products according to full specifications and designs provided by another manufacturer — required to submit information to the Subjects of Concern In articles, as such or in complex Products (SCIP) database if they do not place products in the European Economic Area (EEA) market, and only make products according to customer-approved bills of materials or specifications?

Answer — Raj Takhar: If a contract manufacturer does not place a product directly into the EEA, then SCIP database reporting requirements fall onto either the contract manufacturer’s customer or the importer responsible for bringing the finished product into the EEA.

Question: If a product has a Conformité Européenne (CE) Certification, does the manufacturer also need to prepare a separate Restriction of Hazardous Substances (RoHS) Directive certificate or declaration documentation?

Answer — Bruce Jarnot: A CE marking certifies the product meets all requirements of the respective CE marking law (e.g. Radio Equipment Directive, Electromagnetic Compatibility Directive, Low Voltage Directive, RoHS Directive, etc.). A declaration of conformity (DOC) is required for all products in scope of CE marking laws and must include the harmonized standards used to meet the requirements of the respective laws. The only harmonized standard for the RoHS Directive is EN 63000 (IEC 63000).

Companies should also verify that the on-product CE marking is up-to-date and covers the expanded list of currently restricted RoHS substances, not only the original six. For more information, refer to Assent’s Supplier Help Center article on RoHS Declaration Acceptance Criteria.

Question: What are the SCIP database reporting responsibilities for European Union (EU)-based product distributors? Do they need to enter product information, or is this the manufacturer’s responsibility?

Answer — Valerie Kuntz: Distributors must confirm applicable product information exists in the SCIP database before products are placed on the market. A distributor would only need to enter the information themselves if the manufacturer has not already done so.

Because the manufacturer is closest to the actual product manufacturing process, whenever possible, it is best for the manufacturer to submit information to the database rather than the distributor.

Question: Other than the product label, where should the EU Medical Device Regulation (MDR) symbol labels be shown?

Answer — Raj Takhar: Based on official guidance from MedTech Europe, labels must be placed on the medical product’s “instructions for use” document at a minimum. However, an EU MDR notified body may also require the information to be displayed on the product’s packaging and/or the product itself as a condition of the device’s approval.

It is best practice to include these labels in and/or on the device’s packaging information. Also note that the symbols used on medical device labels under EU MDR are still undergoing ISO consideration and may be subject to change.

Question: If a company only supplies a customer a single type of product (e.g. computers), can they provide a “blanket” Registration, Evaluation, Authorisation and Restriction of Chemical (REACH) Regulation declaration for all related goods, or should they provide individual declarations?

Answer — Bruce Jarnot & Travis Miller: In the provided example, a company could use a blanket REACH declaration that would cover computers and related goods such as keyboards and mice. However, blanket declarations may not be a good idea. A more specific declaration would help prevent inaccuracy and allow for a standalone declaration in the future if the company in question expanded its offerings or was asked to supply a one-time order of a different product.

For more questions and answers, visit the last edition of Assent’s Ask the Experts blog.

Assent’s regulatory subject matter experts frequently participate in events such as webinars to educate compliance professionals. They also inform our clients’ regulatory programs. To learn more, contact us today.

James Calder
SVP, Strategic Channels & Corporate Development

James leads the Corporate Development function at Assent, creating and executing on strategies to increase strategic partnerships and channel sales, and identify growth opportunities through mergers  Read More

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