Active and Non-Active Medical Devices
Conformity Assessment for Your Medical Devices
When it comes to medical devices, quality and safety are especially vital. As a notified body, we can help you with your conformity assessment procedure and ensure that your active and non-active medical devices comply with EU Directive 93/42/EC. Tap into the European market!
Benefits at a Glance
Product tests and certifications by TÜV Rheinland let you:
- Communicate your high standards of quality
- Boost your customers' confidence in the quality and reliability of your medical devices
- Offer your customers essential guidance in choosing a product
Our Services for Your Medical Devices
- Conformity assessment procedure based on Annexes II, III, IV, V, and VI of the Medical Device Directive
- Certification as a "tested medical device"
- Examination of your technical documentation for compliance with Annex VII of the Medical Device Directive
- Inspection of your medical devices for compliance with harmonized standards, for example: EN 60601 or EN 12182
Example of a Conformity Assessment Procedure based on MDD (direttiva dispositive medici), Annex II
1. Technical Documentation
We determine the number of technical documents to be reviewed as specified in he NBOG 2009-4 norm. We then review your technical documentation for compliance with the Medical Device Directive.
2. Product Design Examination (for Class III only)
Our experts examine your entire product design documentation (design dossier) for compliance with Directive 93/42/EC. If the design review is successful, our certification body issues an EC design examination certificate.
3. Optional Preliminary Audit
You define the scope, and we provide a report showing where improvements can be made.
4. Initial Certification Audit
We audit your site to determine whether you are eligible for certification or analyze all the required information, e.g., your quality management documentation. We provide you with a report of the results.
Prior to the audit, you receive an audit plan. During the audit, we review company processes, production facilities, and products for compliance with the directive and other standards. The audit team includes an expert in the relevant product category or categories. You then receive a detailed audit report.
If the results of the audit are positive, you receive an approval for the conformity assessment procedure. This is followed by a regular surveillance audit every 12 months, and recertification every 5 years.
6. Declaration of Conformity
Upon successful completion of the audit, you can issue the declaration of conformity for your products and market them with the CE mark, including the ID of the notified body TÜV Rheinland Italia (1936) - TÜV Rheinland LGA Products (0197).
Legal Standards of our Services
As a manufacturer of active and non-active medical devices, you cannot market your products on the European market unless you meet the basic requirements EC Directive 93/42/EEC (MDD), Annex I.
Every manufacturer must define the intended purpose of their medical devices and classify them based on Annex IX of Directive 93/42/EC on medical devices. The directive distinguishes between four risk classes (class I + 1M - with measuring function, class IIa, class IIb, and class III). Classification may be based on the following criteria:
- Duration of use
- Active or non-active medical device
- Use in the central circulatory or nervous system
- Use of materials of animal or human origin
Defining a Conformity Assessment Procedure
Depending on the classification of your medical device, your conformity assessment procedure may have to be conducted by a conformity assessment procedure. The following assessment modules are available:
- EC type examination
- EC verification
- Product design examination
- Technical documentation review
- Quality management system audit