The EU MDR Medical Device Regulation was published in 2017 as a comprehensive revision of previous directives and has been valid since May 25, 2017. 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 IVD Directive 2017-746 of April 2017. Harmonized standards are used as well to demonstrate compliance with the essential requirements. As of May 26, 2021, with the end of the extended transition period, the requirements of the EU MDR must now be met by medical device companies.
The EU's goal of the Medical Device Regulation was to provide a robust, reliable, transparent and sustainable regulatory framework for all medical device manufacturers, which serves product safety and patient safety and at the same time promotes innovation. Orienting oneself here, implementing the relevant amendments in a targeted manner or implementing them for the first time can sometimes be a challenge for companies in the medical devices industry.
Compliance with the EU Medical Device Regulation
While certification according to old and new law was still valid during the transition period, medical device manufacturers - with only a few exceptions and additional transitional provisions - must now submit an EU certificate according to EU MDR for placing products on the market.
By practical experience it became evident, that not all actors in the supply chain are yet familiar with the new requirements. Furthermore, with regard to implementation, there are still urgent questions that need to be answered by the EU Commission. How should the affected companies proceed here? The new EU MDR brings far-reaching changes - the broadest possible and most comprehensive preparation is required to ensure compliance with the EU MDR requirements. This applies to all economic actors involved throughout the entire life cycle of the medical device: Manufacturers, Authorized Representatives / Agents, Importers, Distributors, Providers of Systems / Treatment Units according to Article 22 (1, 3).
The task is to identify and assign the applicable amendments in a targeted manner and to integrate them into the existing QM system in a lean and efficient way.
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.
- ISO 13485:2016 as standard - this is not a "hard" requirement of the EU MDR, but a general expectation of Regulatory Authorities and Notified Bodies.
- A PRRC "Person responsible for Regulatory Compliance" is required
- 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 now 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 performing a gap analysis of the Technical Documentation and the QM system to identify any need for adaptation. 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 & coordination with the Notified Body.
MDR Consulting and Implementation Based on Many Years of Practical Experience - for Tailored Solutions
gempex experts with many years of industry experience across the entire medical device supply chain, support medical device companies with practical expert support. Solutions are not offered in a prefabricated form, but are individually tailored to the needs of the customer and, if desired, the implementation of the defined measures is accompanied. gempex supports medical technology companies throughout the entire product life cycle.
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
- Targeted, individual adaptation of the QMS
- Structured approach, efficient measures
- Moderate action, secure implementation
- Experienced preparation and support of necessary audits