Directive on active implantable medical devices correctly applied: These requirements result for your CE-compliant product

• Council Directive 90/385/EEC on active implantable medical devices (AIMDD) (1990)
• Council Directive 93/42/EEC on medical devices (MDD) (1993)
• Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostics (IVDMD)

• Implantable cardioverter defibrillators
• Artificial hips
• Pacemaker
• Breast implants
• Spinal screws, rods and artificial discs (spinal fusion hardware)
• IUDs (Intra-Uterine Devices)
• Metal screws, pins, plates and rods (traumatic fracture repair)
• Artificial knees
• Coronary stents
• Ear tubes (tympanostomy tubes)
• Artificial eye lenses

Class I: (low risk)

Class IIa: (medium risk)

Class IIb: (medium/higher risk)

Class III: (high risk)

AIMDs and their accessories are assigned to Class III and are therefore subject to the strictest regulations and permanent monitoring throughout their lifetime.

• Determination of the applicable EU Directive
• Classification of the device
• Implementation of a quality management system (mostly ISO 13485 for implantable medical devices)
• Compilation of a technical and a design dossier
• Applying of Clinical Evaluation Report (CER) to MEDDEV 2.7/1 rev4/MDD/MDR
• Appointment of a European representative acting on behalf of the manufacturer within the EU if the manufacturer is located outside Europe
• QMS and audit of technical and design dossiers by a notified body
• Approval of CE marking and ISO 13485 certificates issued by notified body
• Preparation of the declaration of conformity

• Include a Post Market Surveillance & Product Vigilance (PMS) plan and PSUR or PMS report as required in Annex III of the MDR
• Requirements for the scientific quality and comprehensibility of technical documentation are increasing, especially regarding clinical data
• Basic UDI DI is the primary identifier of the device model and key to records in the UDI database; used in relevant certificates and EU declarations of conformity
• Provision of an "implant card"; part of the marking; integration into technical documentation; allows identification of the product
• Information required to demonstrate compliance with GSPR
• Notified body may require that all information and documentation required to demonstrate the conformity of a product be presented in an EU official language easyCE will be happy to assist you in converting your dossier to the new Medical Device Regulation.

• Audits of the notified body
• QMS
• Development process
• Production process
• Design History File (construction traceability)
• Device Master Record (production reference)
• Post-market data
• Continuous monitoring via electronic database

It therefore covers the design, development, verification and validation of the product for clinical performance and the regulatory status of the product in the target markets. In addition, the MDR requires a closed process implemented with data from post-market monitoring of the product (PMS) to ensure early vigilance against hazards, so that the "To continuously meet General Safety and Performance Requirements (GSPRs) and ensure that benefits outweigh risks by implementing an appropriate risk management system.

It is important to ensure that the documentation generated during a design and development review is securely stored in the technical documentation in the form of either Design History File (DHF) or Device Master Record (DMR).

user feedback and complaints. New inputs based on post-market data can initiate a new cycle in the design and development process. Design change controls can be implemented to introduce corrective and preventive measures that are essential for demonstrating continuous compliance with GSPRs.

• Construction plans
• Design review results according to the company's development protocol
• Design input requirements and specifications
• Traceability of the development process
• Draft of the output documents
• Information on component testing
• Information on material biocompatibility
• Verification results (other valuable verification and validation protocols)
• Validation results (identification, methods, data, people, etc.) for first finished devices
• Risk management activities
• Activities to the human factor
• Software verification and validation, if applicable
• Sterilization information, if applicable
• Packaging verification and validation, if applicable

In addition, useful DHF information includes (but is not limited to) the following:

• Sketches
• Design drawings
• Draft procedures
• Drafts of work instructions
• Drafts of forms
• Suitable photos

2. Designation of authorized representatives: In accordance with Article 11, "if the manufacturer of a product is not established in a Member State, the manufacturer shall designate a sole legal representative". The legal representative must provide, among other documents, a copy of the technical documentation and thus ensure effective communication in connection with the manufacturer's obligations to the BS.

3. Notified bodies for active implantable medical devices: The selection of a suitable Notified Body for an active implantable medical device is important. Notified bodies are responsible for ensuring the safety and conformity of all active implantable medical devices placed on the EU market.

4. A notified body may be selected from the full list of notified bodies of the European Commission. This is available on the NANDO website and currently contains 19 Notified Bodies, of which 6 are based in Germany.

5. Archiving periods for technical documentation: The technical documentation should be stored securely and protected from unauthorized access and modification. According to the AIMDD/MDR legislation, manufacturers are obliged to keep the technical documentation for implants available for BS for a period of at least 15 years after the last product has been placed on the market.

• EN 556-2:2015,
• EN ISO 11137-1:2015,
• EN ISO 11137-2:2015

and in particular

• EN ISO 13485:2016 for medical devices - requirements for quality management systems.

• Determination of qualitative and quantitative product characteristics,
• Identification of possible hazards,
• Risk assessment for each hazard,
• Determination of the risk level and
• Implementation of risk mitigation procedures.

• Ensure that the general safety and performance requirements set out in Annex I of the MDR are met.
• Check that the technical documentation meets the new requirements and provides the necessary proof of conformity.
• Update the technical documentation according to the medical device classification concerned.
  • For products already on the market, you create a well-founded clinical evaluation according to the requirements of the MDR.
  • For new products, start collecting PMS data for the products as planned. Meddev 2.7.1 rev 4 can serve as a guide to the methodology of documentation of clinical data.
• The technical documentation shall be drawn up in accordance with Annexes II and III to the MDR.
• Implement all necessary markings according to UDI number on the medical device in accordance with Article 27 of the MDR.
• Identify a person responsible for compliance.
• Ensure the availability of technical documentation for the agent.

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