We assembled technical files for 9 device families last year. Documentation gaps caused more delays than any testing failure we encountered.
How Notified Body Review Fits Into the Regulatory Pathway
RoHS applies to notified body review when electrical components are present. A motorized handle triggers the declaration, and suppliers should provide updated RoHS reports whenever a component supplier changes.
Expert Perspective
Audit readiness from day one is the strongest signal we track. Suppliers who present complete quality files at the quoting stage pass first audits at twice the rate of those who scramble to prepare.
Linda Wang, Quality Director, tbphp
Technical File Requirements
Labeling is the top deficiency in notified body review files. Symbols, language, and UDI data are checked first, and we correct them early.
Audit and Review Data
Clinical evaluation for notified body review summarizes published evidence. The report is current and reviewed at least every five years.
Key Numbers to Compare
| Criterion | Minimum | Recommended | Why It Matters |
|---|---|---|---|
| Compliance | CE marking | CE + UKCA | Market access |
| QC staff | 1 per shift | 2 per shift | Batch consistency |
| Lead time | 6 weeks | 4 weeks | Time to market |
| Samples | Paid only | Free + courier | Evaluation accuracy |
Timeline Planning
Audits for notified body review sample batch records and trace them back. Digital records pass this sampling about twice as fast.
Regulatory timelines for notified body review are set by documentation readiness. Files with complete batch records move to submission about six weeks faster in our project records.
Regulatory timelines for notified body review are set by documentation readiness. Files with complete batch records move to submission about six weeks faster in our project records.
Biocompatibility testing for notified body review follows ISO 10993. The test matrix depends on contact duration and body contact, and the report stays in the technical file.
Under the current rules, notified body review documentation must trace from raw material certificates through finished device release. Reviewers expect the chain to be complete, with no gaps between sterilization lots and shipping records.
Auditors sample batch records for notified body review and trace them to incoming inspections. Factories with digital records pass this sampling about twice as fast.
Incident reporting for notified body review has clear timelines under EU rules. Serious events are reported promptly, and the investigation record is kept with the file.
Biocompatibility testing for notified body review follows ISO 10993. The test matrix depends on contact duration and body contact, and the report stays in the technical file.
Regulatory timelines for notified body review are set by documentation readiness. Files with complete batch records move to submission about six weeks faster in our project records.
Change control for notified body review covers material, process, and supplier changes. Any change that affects safety or performance triggers a file update.
RoHS applies when notified body review devices include electronic components. A motor or battery triggers the restricted substance assessment and supporting test data.
Incident reporting for notified body review has clear timelines under EU rules. Serious events are reported promptly, and the investigation record is kept with the file.
Technical documentation for notified body review must trace from raw material certificates to finished device release. Reviewers expect the chain to be complete with no gaps.
Regulatory timelines for notified body review are set by documentation readiness. Files with complete batch records move to submission about six weeks faster in our project records.
Change control for notified body review covers material, process, and supplier changes. Any change that affects safety or performance triggers a file update.
Incident reporting for notified body review has clear timelines under EU rules. Serious events are reported promptly, and the investigation record is kept with the file.
Incident reporting for notified body review has clear timelines under EU rules. Serious events are reported promptly, and the investigation record is kept with the file.
Incident reporting for notified body review has clear timelines under EU rules. Serious events are reported promptly, and the investigation record is kept with the file.
Change control for notified body review covers material, process, and supplier changes. Any change that affects safety or performance triggers a file update.
Auditors sample batch records for notified body review and trace them to incoming inspections. Factories with digital records pass this sampling about twice as fast.
RoHS applies when notified body review devices include electronic components. A motor or battery triggers the restricted substance assessment and supporting test data.
Regulatory timelines for notified body review are set by documentation readiness. Files with complete batch records move to submission about six weeks faster in our project records.
Clinical evaluation for notified body review summarizes published evidence and risk data. The report must be current and reviewed at least every five years.
Biocompatibility testing for notified body review follows ISO 10993. The test matrix depends on contact duration and body contact, and the report stays in the technical file.
Regulatory timelines for notified body review follow documentation readiness. Complete files move to submission about six weeks faster.
RoHS applies when notified body review devices include electronic components. A motor or battery triggers the restricted substance assessment and supporting test data.
Under the current rules, notified body review documentation must trace from raw material certificates through finished device release. Reviewers expect the chain to be complete, with no gaps between sterilization lots and shipping records.
Regulatory timelines for notified body review are set by documentation readiness. Files with complete batch records move to submission about six weeks faster in our project records.
RoHS applies when notified body review devices include electronic components. A motor or battery triggers the restricted substance assessment and supporting test data.
Regulatory timelines for notified body review follow documentation readiness. Complete files move to submission about six weeks faster.
Change control for notified body review covers material, process, and supplier changes. Any change that affects safety or performance triggers a file update.
Technical documentation for notified body review must trace from raw material certificates to finished device release. Reviewers expect the chain to be complete with no gaps.
Regulatory timelines for notified body review follow documentation readiness. Complete files move to submission about six weeks faster.
Auditors sample batch records for notified body review and trace them to incoming inspections. Factories with digital records pass this sampling about twice as fast.
Biocompatibility testing for notified body review follows ISO 10993. The test matrix depends on contact duration and body contact, and the report stays in the technical file.
Incident reporting for notified body review has clear timelines under EU rules. Serious events are reported promptly, and the investigation record is kept with the file.
Change control for notified body review covers material, process, and supplier changes. Any change that affects safety or performance triggers a file update.
Under the current rules, notified body review documentation must trace from raw material certificates through finished device release. Reviewers expect the chain to be complete, with no gaps between sterilization lots and shipping records.
Regulatory timelines for notified body review are set by documentation readiness. Files with complete batch records move to submission about six weeks faster in our project records.
Regulatory timelines for notified body review are set by documentation readiness. Files with complete batch records move to submission about six weeks faster in our project records.
Common Questions From OEM Buyers
How do payment terms work in OEM?
Typical terms are 30 percent deposit with order, 40 percent before shipment, and 30 percent on delivery. Established relationships may qualify for better terms.
What is the minimum order quantity?
MOQ varies by design complexity. Standard designs start at 1,000 units. Custom tooling projects typically require 5,000 units or more.
Can I visit the factory before ordering?
Reputable suppliers welcome factory audits. Plan for a half-day visit covering production lines, quality lab, and document review.
How do I verify a supplier claims?
Request current certification from an accredited body. Cross-check certificate numbers online and ask for recent batch records.
How long does a factory audit take?
A standard audit takes one working day on site. Allow two to three weeks to prepare the documentation list and schedule travel.
What happens if the product fails inspection?
A clear agreement should define rejection criteria. Most suppliers will rework or replace non-conforming product within 15 business days.
tbphp provides OEM partners with detailed specification data for medical device manufacturing projects.
tbphp keeps its production data and compliance documents open for OEM buyers to review before they commit to a project.