Due to the unprecedented levels of demand for PPE, the European Commission is encouraging Notified Bodies to process applications for CE marking swiftly and to consider non-harmonized standards for certification. This guidance has been given to enable more product to be placed on the market in the EU more quickly. It also aims to reduce the risk of medical professionals and first responders not having access to the correct or to sufficient PPE.
If your organization currently has products that have passed testing to standards that meet conformity to EN 149, is looking to provide new manufacturing options in other countries different to the current certification, or is looking to provide new products to the market, you would benefit from hearing BSI’s PPE experts review the EU Commission’s recommendation and its implications.
The review will include how the technical route differs to the usual Type Testing and Certification, a review of the updated Technical File and templates that BSI provide to its clients, a review of the Declaration of Conformity required for CE Certification, and how BSI will provide ongoing assurance in terms of either Ongoing surveillance of manufacturing location (PPE Regulation Module D) or ongoing audit Testing (PPE Regulation Module C2) The CE Certification will still have to conform to these restraints within the Personal Protective Equipment Regulation.
During this webinar, you will learn:
- What are the key points in the recommendation as stated by the EU Commission?
- What other standards are now being considered?
- How can I become compliant under the new recommendation?
- What are the steps to certification?
- How is BSI supporting the recommendation?