European Commission undertook a change of legislative framework, and upon 5 years of revision, the final drafts of Medical Devices Regulation (MDR) Regulation (EU) 2017/745 and In Vitro Diagnostic Medical Devices Regulation (IVDR) Regulation (EU) 2017/746 were published in 2016. Following the adoption by the EU member countries in March 2017, the Regulations entered into force on May 25, 2017 and became effective in EU member countries.
The MDR Regulation will replace the Medical Device Directive (MDD) 93/42/EEC and the Active Implantable Medical Devices Directive (AIMD) 90/385/EEC and integrate and upgrade the original medical device Directive into Regulation to enhance the binding to EU member countries. The new Regulations improve the specification and constriction to medical material certification, for example, increase to 20 specifications for the medical material classification, enhance the traceability of medical materials, preciseness of clinical trial specification, understanding of clinical evidence and strengthen the post-market product safety and efficacy supervision.
Summary of the key changes:
1. Definition and classification of medical devices
2. Update of classification of in vitro diagnostics equipment
3. Strengthen the clinical assessment and clinical evidence supervision
4. Improve the transparency and traceability of the products to the patients
5. Post-market surveillance system
According to MDR, Distribution agents in the European Union are jointly liable for defective medical devices, which may urge the agents verify the non-EU manufacturers prudently before cooperation or seek insurance policies to cover additional residual risks.
In response to the technical development, the new EU Regulations include many changes, such as medical software, network security. According to Rule 11 of Appendix 8 Classification Rule of Medical Materials, instructions on software and software medical materials are included, covering Class I to Class III. Moreover, the Regulations also include many special rules for medical instrument combination products, tissue engineering, nanoscience and so on, for example, MDR provides special classification rule for the medical material containing nano materials. The nano materials can be divided into class IIa to Class III based on the in vivo exposure, the medical material used as disinfectant or sterilizer of invasive equipment are class IIb material.
European Union is the second largest medical device market in the world, the new Regulations are stricter on the product safety, performance assessment, clinical evaluation and post-market safety supervision, and strengthen the technical review and require traceability of product supply chain. To comply with the new Regulations, the manufacturers should import relevant standards to ensure the compliant products R&D and manufacturing, which will increase the product development cost for the medical material manufacturers.
The MDR includes 3 years of transitional period, it will fully replace the AIMD and MDD in 2020, and the authentication certificate will become void in 2024 according to MDD and AIMD directives. It suggests that even the certificated products will re-apply CE marking and must collect the evidence of clinical supervision of the products in PMCF. With the increase of regulation level, the CE Mark is no longer the representative of advanced medical market with lower regulatory threshold. It is not easy as before for the manufacturers to obtain the first marketing approval via the EU market, thus we can see that the issuance of MDR brings great impact to the business layout of medical material manufacturers.
The codes of new regulations are EU 2017/745 for MDR and EU 2017/746 for IVDR.