The EU MDR Medical Device Regulation 2017/745 EU was published in 2017 as a comprehensive revision of previous directives. It thus replaces the Medical Device Directive 93/42/EEC and the Active Implantable Medical Devices Directive 90/385/EEC. Basic requirements, classification and conformity assessment procedures of in vitro diagnostics are regulated in the IVDR 2017-746 EU, which also came into force in 2017. With the end of the extended transition period in May 2021, the requirements of the EU MDR must now be met by medical device companies.
gempex supports medical device companies and their suppliers comprehensively so that they can continue to place effective and safe medical devices on the market in accordance with the requirements. Customers can make use of gempex’ regulatory knowledge and structured project approach, and unlock advantages.
Challenge EU MDR - What has Changed?
Numerous requirements have become more stringent with the new EU MDR, while others have been added for the first time. For example:
- Advanced and more detailed requirements regarding the Technical Documentation including continuous updating. Introduction of "Common Specifications" by the EU Commission.
- Increasing the basic requirements from the former 'Essential Requirements' to now 'GSPR - General Safety and Performance Requirements'.
- Ambitious requirements for the Quality Management System, now also as new requirements in lower product risk classes.
- A PRRC "Person Responsible for Regulatory Compliance" is required
- Tightening or even addressing for the first time the responsibilities of all economic actors involved in the life cycle of the medical device: not only manufacturers, authorized representatives / agents and importers are addressed, but also distributors, providers of systems / treatment units, sterilizers and even in-house manufacturing e.g. in hospitals
- Re-classification of products: some former Class I products are now assigned to a higher product risk class, such as software, reusable surgical instruments or products with measuring function.
- Introduction of Scrutiny procedure: Involvement of expert panels for conformity assessment of high-risk devices. The MDCG Medical Device Coordination Group may request expert panels to provide scientific opinions on the safety and performance of a device.
- Reorganization of reporting deadlines and market surveillance, preparation of PMCFs Post Market Clinical Follow-ups and PSURs Periodic Safety Update Reports.
- Previously known PLM/OEM constellations do no longer exist.
To keep track of these regulations requires in-depth knowledge and reliable interpretation of the new regulations. gempex experts provide support in interpretation and implementation.
Ensuring EU MDR Compliance
What does a medical device company have to do in order to ensure that its products are placed on the market in accordance with the requirements of the EU MDR and in connection with the MPDG Medizinprodukterecht-Durchführungsgesetz?
It is important to verify the product/ and product family classification and to determine how the products must be registered according to the EU MDR. gempex recommends a gap analysis of the Technical Documentation and the QM system to identify any need for adaptation. MDR Consulting. It is helpful to create a compliance plan that defines the strategy and steps to comply with regulatory requirements. A project team, established by top management, ensures the structured implementation of the plan defined. It is also important to ensure timely communication and coordination with the Notified Body or applicable regulatory authorities.
MDR Consulting and Implementation Based on Many Years of Practical Experience - for Tailored Solutions
With many years of industry experience across the entire medical device supply chain, gempex provides professional support to companies throughout the entire product life cycle. Solutions are individually tailored to the needs of the customer and, if desired, the implementation of the defined measures is accompanied. MDR consulting and implementation.
A specific gap analysis provides a clear picture regarding possible fields of actions. Remediation activities follow, like ensuring a compliant Technical Documentation or the revision of the Risk Management System according to ISO 14971:2019, in order to prepare product approvals in the best possible way.
If necessary, SOPs and work instructions, or the entire Quality Management System, are revised in accordance with the requirements of ISO 13485:2016. The scope of services also includes the evaluation of the Supplier Management System or updating Quality Assurance Agreements. The range of services is rounded off by support in preparing and directly accompanying the qualification audit on site, employee training or taking over communication with the Notified Body. Full service or individually selectable components - just as you wish.
- Navigate the new regulations with confidence
- Effective identification of required adjustment for all economic actors
- Targeted, individual adaptation of the QMS
- Structured approach, efficient measures
- Moderate action, secure implementation
- Experienced preparation and support of necessary audits