The new EU Medical Device Regulation (MDR)
In order to implement a consistent and transparent system that guarantees an effective product overview and traceability, important innovations in medical device law within Europe are about to be introduced. The new Medical Device Regulation (MDR) 2017/745/EU came into force in May 2017. After a 3-year transitional period up to May 2020, the MDR replaces Medical Devices Directive (MDD) 93/42/EEC and the Directive on active implantable medical devices 90/385/EEC. The MDR will be mandatory for all new products from May 26, 2020. The new requirements according to Annexes II and III of the MDR will result in increasing and exacting documentation and verification obligations. Despite the period available during the transitional period, we advise our clients to start preparing as soon as possible. Further details can be found in the download area under customer information about the MDR.
Important changes for manufacturers of medical devices
Expansion of the Product Scope of Application
A new classification under the MDR has to be carried out by the MD manufacturer.
MDR source:
Article 51: Classification
Strict Clinical Surveillance after Placement on the Market
The responsibility of the MD manufacturer with regard to the safe medical use of the medical devices is defined as being more stringent with respect to market surveillance and is subject to systematic documentation.
MDR source: Articles 83-100:
Market surveillance
Joint Specifications
In the absence of harmonised norms/standards under the MDR, due account should be taken of the health requirements of the Member States and the public.
MDR source:
Article 9: Joint Specifications
Reclassification of Products according to Risk, Contact Duration and Invasiveness
A new classification under the MDR has to be carried out by the MD manufacturer on the basis of the latest scientific findings and the post-market surveillance data that have been obtained.
MDR source:
Article 51: Classification
Systematic Clinical Assessment of Class IIa and IIb Medical Devices
The responsibility of the MD manufacturer with regard to the safe medical use of the medical devices is defined as being more stringent.
MDR source:
Article 61: Clinical Assessment
Articles 62-80: Clinical Testing
Stricter Clinical Evidence for Class III Medical Devices and Implantable Medical Devices
The responsibility of the MD manufacturer with regard to the safe medical use of the medical devices is defined as being more stringent.
MDR source:
Article 61: Clinical Assessment
Articles 62-80: Clinical Testing
Designation of a Qualified Person for Compliance with the Legal Provisions
The MD manufacturer has to provide a clear definition of responsibility with minimum requirements for training/knowledge.
MDR source:
Article 15: Qualified Person
No Protection of Existing Rights
A time limit for the approval of medical devices up to now is necessary due to the increased requirements placed on the clinical data, traceability with the UDI and the market observation tasks.
MDR source:
After the transitional period, medical devices approved under the MDD may be placed on the market until May 2025 at the latest.
Implementation of the Unique Product Number System
The traceability of the individual medical device should be made possible without any gaps on the basis of the free movement of traded goods.
MDR source:
Article 27
Entry into force and date of application of the unique product number system (Article 27, Section 4)
Deadlines for products in classes I-III
Implantable Products and Class III Products
Class IIa and IIb Products
Class 1 Products
Deadlines for reusable products
Commencement of Validity
Changeover for Products with UDI Carriers
Changeover for Reusable Ir Products