As of April 2017, the EU adopted the new Medical Device Regulation (MDR 2017/745), replacing the two existing directives, the Medical Devices Directive and the Active Implantable Medical Devices Directive:
- Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
- Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
What will the changes be?
The aim of the new regulation (MDR 2017/745) is to improve weaknesses in the old directives as well as capture the swift evolution of science and technology in the field of medical devices. To do so, it introduces a number of key improvements such as:
- stricter ex-ante control for high-risk devices via a new pre-market scrutiny mechanism with the involvement of a pool of experts at EU level;
- the inclusion of certain aesthetic devices which present the same characteristics and risk profile as analogous medical devices under the scope of these Regulations;
- improved transparency through the establishment of a comprehensive EU database on medical devices and of a device traceability system based on Unique Device Identification;
- the introduction of an “implant card” containing information about implanted medical devices for a patient;
- the reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorisation of multi-centre clinical investigations;
- the strengthening of post-market surveillance requirements for manufacturers;
- improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance.
How can your company prepare for the transition?
Based on the activities to take into consideration, the amount of work is substantial from a quality assurance perspective. Companies should start now to make sure their processes are compliant by May 2020. Here are some tips to get started:
- Understand the new legislation and the changes from the current Medical Devices Directive consulting an EMA regulatory expert;
- Conduct thorough gap assessments to review your current products and processes against the new legislation;
- Bear in mind that the management system standard for medical device manufacturers – ISO 13485 – has also been updated. The final date for transitioning to the new edition (ISO 13485:2016) is February 28, 2019.
- Review your company’s SOPs and QA processes to be sure they are in line with regulations
In seQure, we are already working with our clients to be compliant with the new regulation. Therefore if you are searching for a strategic partner as an industry leader in Quality Management Systems, we can offer you advanced solutions for Quality and Compliance in all GxP areas with a network of experts with over 20 years of experience.
seQure Life Sciences Services and Consultancy for Quality Management and Assurance:
- Quality Management Services: from process assessment to implementation, analysis and system improvement
- Standard Operating Procedures (SOPs), Policies: creating documents and tools to improve readability and compliance
- GxP Audits: from defining client processes to planning, conducting and reporting
- Quality and compliance for pharmacovigilance: from system assessment to third party audits
- Training: analysis and assessment of training needs
- GxP Inspections: from assessment of compliance status, gaps and needs to supporting clients in the preparation and management of inspections
- System and Database Audits, Software House Audits, Suppliers and Service Providers