Service Schemes for Medical Device Export to
the European Market
If you are a PPE enterprise, and you want to enter the European market, we provide you with the following service schemes according to product classification:
1. Simple design products
2. Medium design products
3. Complex design products
1. Simple design products
PPE application of simple design products
For the simple design PPE, it is only required to complete the CE technical documentation that meets the requirements of EU 2016/425 (PPE), and then the export to Europe can be self-declared. (For example, sunglasses, gardening gloves, etc.)
Timing of PPE application of simple design products
For PPE manufacturers, once there are products to be exported to Europe, they must prepare the CE technical documentation in advance. The technical documentation must includes the instructions for use, risk analysis reports, basic requirements checklists, and testing reports, and then the enterprises can self-declare the export.
Process and cycle of PPE application of simple design products
1) Collect the information needed to prepare the technical documentation: enterprise information, instructions for use, product testing reports, pictures of product packaging labels, etc.;
2) Prepare the technical documentation;
3) Perform the internal review on the prepared technical documentation;
4) Rectify the nonconforming items pointed out in the review;
5) Continue the review after completing the rectification, and deliver the documentation to the enterprise if there is no problem.
Cycle: the preparation of PPE technical documentation for simple design products will be finished about 2 weeks after the enterprise provides the complete information.
2. Medium design products
PPE application of medium design products
For the export of medium design PPE to the EU, product testing and CE technical documentation must be completed in accordance with the corresponding product standards, and then the PPE authorized notified body will conduct the CE certification and issue the certificate.
Timing of PPE application of medium design products
For PPE manufacturers, once there are products to be exported to Europe, they must prepare the CE technical documentation and product type examination reports in advance, and then the PPE authorized notified body will conduct the CE certification and issue the certificate, so as to comply with the EU’s customs clearance requirements.
Process and cycle of PPE application of medium design products
1) Guide the sample preparation;
2) Send the samples to the laboratory for testing;
3) While sending the samples, collect the information needed to prepare the technical documentation;
4) Prepare the technical documentation;
5) Issue the EC type test certificate;
Cycle: according to the normal testing cycle, plus the preparation and review of technical documentation, the process is usually completed in about 3 months.
3. Complex design products
PPE application of complex design products
Complex design PPE is subject to higher requirements. In addition to meeting the requirements for medium design products, complex design PPE also needs to pass the quality system audit by the certification body or the product sampling inspection every year before it can be exported successfully. (For example, protective masks, protective clothing, etc.)
Timing of PPE application of complex design products
For PPE manufacturers, once there are products to be exported to Europe, they must prepare the CE technical documentation, product type examination reports and quality system documents in advance, and then the PPE authorized notified body will conduct the CE certification and issue the certificate, so as to comply with the EU’s customs clearance requirements.
Process and cycle of PPE application of complex design products (Module B+D)
1) Guide the sample preparation;
2) Send the samples to the laboratory for testing;
3) While sending the samples, collect the information needed to prepare the technical documentation;
4) Prepare the technical documentation;
5) Issue the EC type test certificate;
6) Perform on-site audit and issue the 11B certificate;
7) Issue the CE certificate.
Cycle: according to the normal testing cycle, plus the preparation and review of technical documentation and on-site audit, the process is usually completed in about 4-6 months.
Quotation Scheme for Medical Device
Export to the European Market
Quotation principle for the preparation of PPE technical documentation of simple design products
The quotation for the preparation of technical documentation is mainly determined based on the number of products. Multiple products can share a PPE technical document, which is more expensive than the expense on a single product.
Quotation principle for PPE application of medium design products
The expense consists of three parts: consulting fee, product testing fee, and certification body audit fee.
The consulting fee is determined by the number of products. The more the products, the higher the expense. The product testing fee and audit fee are quoted by the certification body specifically.
Quotation principle for PPE application of complex design products
The expense consists of three parts: consulting fee, product testing fee, and certification body audit fee.
The consulting fee is determined by the number of products. The more the products, the higher the expense. The product testing fee and audit fee are quoted by the certification body specifically.
