EU MDR transition periods - support for successful certification

• Directs the focus on risk and safety aspects.
• Common Specifications (CS) of the European Commission must be applied unless the specifications applied are at least equivalent.
• Regular updating of the Risk Management File (RMF), Clinical Evaluation Report (CER) and Technical Documentation, including Post Market Surveillance (PMS) feedback, must be ensured.
• The requirements for clinical data are increasing. New documents such as the Post Market Clinical Follow-up Plan (PMCF) and the PMCF report must also be produced.
• The labelling and traceability requirements are increasing, UDI is mandatory.

Post Market Surveillance and Vigilance

• The PMS process provides input for a number of other processes. Regular updating of all processes must be ensured.
• Prepare a Post Market Surveillance Plan (PMSP) for each product.
• New process for the Periodic Safety Update Report (PSUR) for Class IIa, IIb and III products
• New process for the Post Market Surveillance Report (PMSR) for Class I products
• Update the Incident and Field Safety Corrective Action (FSCA) reporting processes

Supply Chain

• Clean up your supply chain! Identify critical suppliers, distributors and importers.
• All Economic Operators play a key role in product and patient safety and must meet this commitment. This must be managed by written agreements (QAA-Quality Assurance Agreement).
• All foreign manufacturers must contract an Authorized Representative in the EU.
• The identification and traceability of products must be ensured throughout the supply chain. New processes for documentation, approval, registration and conclusion of written agreements.

New European database for medical devices EUDAMED

• New process for using and uploading EUDAMED information.

UDI (Unique Device Identifier) and labeling.

• New processes for storing and tracking UDI and importing UDI information into EUDAMED
• New labeling requirements
• Keep an up-to-date list of your UDIs

Regulatory compliance

• Document your compliance strategy. Define responsibilities and ensure that qualification requirements are met and documented.

Clinical evaluation and clinical study

• A clinical evaluation per product must be carried out. Unless there is sufficient justification that there is no need.
• If scientific literature is used, evidence of the relevance of the literature must be provided.
• A written report, either included in the technical documentation or referred to in the technical documentation, is required.
• PMCF is a continuous process for updating the clinical evaluation and should be part of the PMSP. The aim is to collect and evaluate clinical data.
• A clinical study must be conducted for all Class III devices and implants. Unless it is duly justified that it is sufficient to rely on existing clinical data.
• Clinical trials may also be required for lower-risk devices, depending on the availability of clinical data from other sources.
• New clinical trial provision: transparency. The sponsor must obtain information from EUDAMED.

Documentation requirements

• New provisions on storage and retention of technical documentation and other records.

1. Gain an understanding for the EU MDR.
2. Identify which of your medical devices need to be certified according to EU MDR.
3. Develop a transition plan.
4. Find an accredited Notified Body and apply for the certification.
5. Check the classification of your products and product groups under EU MDR.
6. Update the technical documentation according to EU MDR requirements.
7. Update your quality management system (QMS) according to the requirements of the EU MDR.
8. Have your quality management system and technical documentation audited by the notified body to gain certification.
9. Fulfil your market surveillance obligations.
10. Prepare for a review by the Notified Body or Authority at any time.

Chemgineering supports you in the implementation of EU MDR requirements at all levels. Together we define the scope of the project in order to systematically create a flexible transition plan tailored to your needs. From development to implementation and through the entire product life cycle.

• Internal Workshops
• EU MDR compliance Consulting: Complaint Handling, CAPA, Supplier Management
• Elaboration of a roadmap to EU MDR Readiness
• Gap analysis of the entire quality management system
• Internal audits for status determination (Supplier & Distributor Audits)
• Preparation and execution of competent authority/NB audits
• QMS remediation and support in the implementation of the measures
• Dynamic UDI solutions in cooperation with projektraum36
• Post Market Surveillance, Clinical Evaluation

Chemgineering is your partner for compliance consulting and plant construction in the GxP-regulated environment. With more than 20 years of experience, we are experienced in the life sciences and yet free enough to come up with fresh ideas. We are GxP experts and make sure that not only is your productivity right, but that you can also look forward to the authorities' inspection with complete peace of mind. Chemgineering accompanies you through the entire lifecycle of your plant and coordinates all the trades you need to realize your project from A to Z.