Final Opportunity for IVDD-Other IVD Product Registration Under EU IVDR Transition Period

With the promulgation of the transitional provisions for the IVDD-to-IVDR transition proposed by the Council of the European Union, an increasing number of manufacturers are beginning to reconsider their strategic portfolio of in vitro diagnostic products for the European market.

Currently, manufacturers of in vitro diagnostic (IVD) products must first comply with the European Union’s In Vitro Diagnostic Directive (IVDD) 98/79/EC to affix the CE Mark to their products and legally sell them within the EU. The IVDD will expire on May 26, 2022. Manufacturers must complete their technical documentation and product registration before this date to qualify for the transitional period provisions, allowing them to continue selling their products in the European market. By taking advantage of the final five months to secure registration, your products can enter the European market earlier through a more streamlined process. If you wait until after May 26, 2022, to register under the In Vitro Diagnostic Regulation (IVDR), the new classification rules may increase the difficulty of market access and raise associated registration costs for your products.

Products registered by May 26, 2022, may be registered under the “other” classification of the current In Vitro Diagnostic Medical Devices Directive (IVDD). However, registrations submitted after May 26, 2022, must comply with the classification requirements of the In Vitro Diagnostic Medical Devices Regulation (IVDR). The IVDR has reclassified in vitro diagnostic products; for instance, COVID-19 RT-PCR reagents are classified as Class D high-risk products under the IVDR, significantly increasing the difficulty of market access following the implementation of the new regulation.

Therefore, registering under the existing In Vitro Diagnostic Devices Directive (IVDD) before May 26, 2022, was the optimal choice in terms of timing, feasibility, and cost-effectiveness. The certification cost for IVDD Class Other devices is relatively low; as this class carries the lowest risk under the IVDD, most Chinese enterprises can afford it by following the self-declaration of conformity (DoC) process without the involvement of a Notified Body. However, under the In Vitro Diagnostic Medical Devices Regulation (IVDR), these devices would be reclassified into higher-risk categories, leading to a substantial increase in overall costs. This would not only involve fees for Notified Bodies but may also require additional clinical evaluation expenses.

Products classified as “other” under the IVDD framework but reclassified as Class A (sterile)/B/C/D under the IVDR regulatory framework, and which completed product registration and filing in the EU through their European Authorized Representative before May 26, 2022, may continue to be legally placed on the EU market until the following dates:

Preparation of DOC for IVDD Other Category Products

Products classified under IVDD – Self-Certified (referred to as “other”) may affix the CE marking without the involvement of a Notified Body, by issuing a Declaration of Conformity (DOC) in accordance with the route specified in Annex III of the IVDD. A key principle in preparing the technical documentation is strict compliance with the “Essential Requirements” set forth in Annex I of the IVDD.

The European Union imposes stringent requirements on the preparation of technical documentation, mandating comprehensive coverage that includes: Declarations of Conformity; information on the manufacturer and/or its authorized representative within the EU; quality system information related to the product; product descriptions; checklists for essential requirements; lists of applicable standards and test reports; risk management documentation; clinical evaluations; and other multifaceted, comprehensive technical information. Furthermore, all technical documentation must maintain content consistency, ensure regulatory compliance, and be written in English.

For enterprises, drafting such a comprehensive technical documentation that spans multiple application domains is extremely challenging, requiring substantial time and collaboration among diverse professional experts. The content mandated for EU technical documentation cannot be easily prepared by regulatory personnel overnight. PureCert boasts a global team of regulatory and clinical experts, including native English-speaking chief specialists who provide end-to-end support for clients’ technical documentation. Meanwhile, our team includes China-based postdoctoral fellows in clinical medicine and academic experts in immunology and cell biology, ensuring readily available local technical support for IVD products with seamless communication. We genuinely help domestic manufacturers achieve European-level technical documentation standards while providing localized communication and service support in China; with professional expertise and premier efficiency, we facilitate your product’s market entry overseas.

We possess extensive experience in European market access, having assisted numerous domestic clients in obtaining CE certification for their in vitro diagnostic (IVD) products. Notably, we have secured multiple registration certificates for products classified under IVDD "Other." PureCert can provide comprehensive technical services and global expert support for your IVDD Self-Certified products (referred to as "Other" category). We will help you complete your technical documentation and product registration before May 26, 2022, allowing you to leverage the transitional period benefits and successfully launch your products into the European market as soon as possible.

↑Success Case: Registration Confirmation Receipt↑

IVDD - Other Category Registration Service Steps

Step 1: Gap Assessment

Step 2: Compilation of IVDD TDF Documents

Step 3: Product Registration

▶ Scenario 1: A single company provides up to 30 products (including registered ones)

We can complete the preparation of IVDD - Others technical documentation and finalize registration within two months after Party A provides all the original data required by us in full. The list of original data to be provided by Party A will be supplied by Party B after the contract is signed.

▶ Situation 2: A single company provides more than 30 products simultaneously (including registered ones)

Upon the Client’s full provision of all original materials required by us, we commit to completing the preparation of all technical documentation for IVDD – Others and finalizing registration for all products by May 26, 2022. The Service Provider shall update the Client on the progress of technical documentation preparation and registration every two weeks. The list of original materials to be provided by the Client will be furnished by us after the contract is signed.

To better serve domestic manufacturers in completing the preparation of technical documentation and EU registration for IVDD-Other products before May 26, 2022, Purui has specially launched a preferential pricing scheme, offering discounted service packages for multi-category products from Chinese IVD manufacturers:

Product Pricing Plan (Including Registration):

RMB 15,500/product (1-5 units)

RMB 13,000/product (6-10 units)

CNY 12,000/product (11–20 units)

RMB 11,000/product (21-30 units)

RMB 10,000/product (31 units and above)

*80% advance payment before project commencement; 20% balance upon completion of product registration.

*The raw IVDD technical documentation provided by Party A shall be in English, and the deliverables provided by Purui Fang shall also be in English. This service quotation excludes translation and other related services.

Please scan the QR code on the poster below to register your interest. Clients who complete the expression of interest form via VCBeat will receive priority service and exclusive discounts!