On May 5, 2017, the Official Journal of the European Union (Official Journal of the European Union) formally released the European Union Medical Devices Regulation (REGULATION (EU) 2017/745, referred to as "MDR").MDR will replace Directives 90/385/EEC (Active Implantable Medical Devices Directive) and 93/42/EEC (Medical Devices Directive). The MDR replaces Directives 90/385/EEC (Active Implantable Medical Devices Directive) and 93/42/EEC (Medical Devices Directive). Pursuant to the requirements of MDR Article 123, the MDR came into force on May 26, 2017 and officially replaces the MDD (93/42/EEC) and the AIMDD (90/385/EEC) with the May 26, 2020 date.
Major changes in product classification in the MDR regulation:
The product classification levels are maintained at four categories, i.e., Class I, IIa, IIb and III.
No change in the principles of classification
Rules of classification: 18 = >22
Rule 3: (New on top of the original)
- For use in vitro in direct contact with human cells, tissues, or organs obtained from the human body or in vitro in conjunction with an embryo = >Class III.
Rule 4: The scope is extended to invasive devices that come into contact with injured mucous membranes.
Rules 6-7: Surgical invasive instruments
- Anticipated direct contact with the heart and central circulatory system = >Class III
Rule 8: Implanted or long-term surgical invasive instruments
- Surgical patches, implants used to infuse drugs, artificial discs, or implants that come into contact with the spinal column (excluding components such as nails, plates, etc.) = >Class III Class
Rule 9: Active devices: those used to control, monitor or directly affect the performance of active implanted devices => Class III. (elevated classification)
Rule 11: Classification of software is refined => I/IIa/IIb/III
Rule 19: Containing nanomaterials, based on the potential risk posed => Class IIa/IIb/III
Rule 20: Invasive devices that are accessed through a natural lumen and are administered respiratorily => ;Class IIa/IIb
Rule 21: Substances or combinations expected to be introduced into the human body or applied to the skin through a natural lumen and absorbed by the body or locally dispersed in the body=> Class IIa/IIb/III
Rule 22: Active therapeutic devices integrating diagnostic functionality which has a significant impact on patient management=>. Class III; e.g., automated external defibrillators, electrocardiographic recording systems
Enhanced manufacturer responsibility
-Designation of a compliance officer
-Continuous updating of technical documentation
-Financial safeguards
More stringent pre-market review
-There will be a pre-market review mechanism for selected high-risk devices, with the involvement of an EU-level expert group for a more rigorous prior assessment.
-Classification of some products becomes higher
-Strengthened requirements for clinical evidence
Improved transparency and traceability
-Use of the Unique Device Identification (UDI) system to identify and track devices.
-Revised, publicly accessible EUDAMED database containing information on device certification and information on clinical studies, vigilance and post-marketing surveillance will be established.
-Patients will receive an implant card with all the essential information
Expanded Scope of Application
-Devices that are not intended for medical use, but whose functional and risk characteristics are similar to those of medical devices, will be similarly included in the scope of the MDR
Enhanced Vigilance and Market Regulation
-Once a device is can be used on the market, manufacturers will have to collect data on their performance and EU countries will coordinate more closely in the area of market surveillance.
Enhanced regulation of Notified Bodies
-Notified Bodies will need to be subject to joint audits
Internal self-checks to ensure that the technical documentation: meets the most recent technical requirements; in particular the clinical evaluation! Meet language requirements
The proliferation of regulatory requirements has had a huge impact on manufacturers (especially SMEs)
Exacerbating the scarcity of talent: manufacturers, Notified Bodies, expert panels, EU Authorized Representatives, etc. need people who are familiar with the regulations, technology and...
Checking product classifications and compliance pathways. Check whether product classification and compliance pathways are affected, understand the MDR changes, do an internal gap analysis, and start preparing as early as possible!