Medical device safety and quality around the world are being addressed in the form of common specifications and standards with variations expected country by country. The EU initiative is just the beginning. Total product lifecycle management is assumed, emphasizing safety backed by clinical data. For the EU EUDAMED database, the new regulations will go into effect starting May 26, 2020 for MDR and May 26, 2022 for IVDR. To begin devising an implementation plan, there are some key areas to be aware of.
1. Post Market Surveillance
The new rules will require vigilance in continually evaluating and improving the quality of risk management information. Medical device registration, Unique Device Identification (UDI), accredited Notified Bodies (NANDO), Serious Incident, Safety and Clinical Performance Reports (SSC), Periodic Safety Update Reports (PSUR), Clinical Data and more will be required to trace information from manufacturer to downstream importation. Reporting on safety in the form of management systems for serious incidents, continuous evaluation of publicly available clinical evaluations and performance and trend reports are the responsibility of manufacturers and EU Authorized Representatives.
2. Unique Device Identification (UDI) & Implant Cards
The UDI placement will be required on the label of the actual device and on all higher levels of packaging (not shipping containers). Implantable devices will be required to carry implant cards with information concerning expected expiration dates of the device and warnings. The UDI will enable traceability and would be a reference in serious incident and Vigilance Reports and Field Safety Actions.
3. Regulatory Compliance Role
Conforming to the new regulations carries a requirement for a designated organizational role, a responsible person within the organization for regulatory compliance. Regulatory expertise is required by either a certification or diploma in a relevant field and at least one year of professional experience or four years of experience in regulatory affairs or in quality managements systems relating to medical devices. Management of nonconformity, Field Safety Corrective Actions, UDI/Labeling and Complaints are responsibilities shared by all in the supply chain.
4. Scope of Product Classifications
For substance-based devices that are absorbed into an orifice or applied to the skin of the human body, specific classification will be enforced, driven by varying factors including the level of invasiveness and potential for toxicity.
For software and applications, new rules may result in some reclassification, even for those devices that were previously exempt.
5. Safety and Clinical Performance Summary
Implantable and Class III devices must include a summary written to inform the users of the product’s safety and clinical performance. Minimally, the summary should include:
- Name of manufacturer and Single Registration Number (SRN)
- Name of the device and Unique Device Identification (UDI)
- Any variants, or other products the device may be combined with
- Intended use instructions including purpose, indications, contraindications
- Any relevant information on post-market clinical follow-up reports
- Risk warnings, precautions, possible side-effects
These are just a few of the medical device regulations enacted by the European Parliament and the Council of the European Union. Medical device manufacturers in the US have experienced the activities driven by FDA compliance and will be ready to build upon those efforts for the EU initiative. Over time, more global regulatory authorities will be posting requirements. To manufacture and distribute all over the globe, pre-planning is key.
As regulatory product data requirements become known by country, Reed Tech will provide the tools and guidance needed to quickly react, and affordably comply, with business critical product data submission requirements wherever they may be mandated.
Reed Tech is prepared to help you build your process step-by-step as we prepare for the EU initiative throughout 2019, anticipating May 2020. Have questions or want to learn more about next steps? Implementation planning now will make for a more productive 2020 timetable. Contact Reed Tech today!
 Manufacturers of Class IIa, II, III devices. Manufacturers of class I devices shall update a post-market surveillance report when necessary to be made available upon request.
 (Official Journal of the EU / 5.5.2017 – Articles 84, 85, 86, 87, 88, 93)
 (IMDRF/UDI WG/N7FINAL:2013)
 (Official Journal of the EU / 5.5.2017- Articles 10, 11, 13, 13, 15, 30)
 (Official Journal of the EU / 5.5.2017 – Article 32)