Support & Opportunities for complying with European MDR
EUROPEAN MEDICAL DEVICE REGULATION
The European Union established the Medical Device Regulation (MDR 2017/745) by publishing the regulations in the Official Journal of the European Union (OJEU) in May 2017. This started the clock on a transitional period that ends with full implementation of the regulation by May 2020. The MDR includes a series of requirements that can have significant implications for medical device manufacturers therefore the transitional period is important. To accommodate the new changes, most manufacturers will find it imperative to update their current processes. Manufacturers that do not comply with the requirements of the regulation by the implementation date may find themselves unable to market their products in the EU after May 2020. The regulations apply to all medical devices marketed in the EU – no grandfathering is permitted so legacy devices will need to meet all relevant requirements, including General Safety and Performance Requirements (GSPR) and the associated technical documentation, taking account of the generally acknowledged “state of the art”. These changes are to ensure that medical device manufacturers are getting safe and effective medical devices to market.
WHAT IS THE EUROPEAN MDR?
Why MDR? Why is it important?
The MDR is the EU’s response to device safety issues that have received broad visibility in recent years. A culmination of events has contributed to this change. The MDR “aims to ensure the smooth functioning of the internal market as regards medical devices” and “sets high standards of quality and safety for medical devices in order to meet common safety concerns as regards such products. Both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the other”.
A key objective of the MDR is to enforce high levels of quality and safety for EU citizens. Organisations that have established methods for complying with the Medical Device Directive (MDD) and/or the Active Implantable Medical Device Directive (AIMDD) and relevant MEDDEV guidance’s may not be greatly impacted by the regulatory changes, although a review with regard to compliance should be undertaken. Legacy products and those being up-classified will require substantial work to achieve compliance to the new MDR.
What are the main changes?
1. The Eudamed database will be updated much of which will be made available to the public e.g. labelling and vigilance information.
2. Unique Device Identification (UDI) is required for products before they reach the market and must be verified periodically after they are released.
3. Certain devices have been up classified e.g. devices in direct contact with the heart or central circulatory system thus requiring a review and possible remediation of technical documentation.
4. There are new, rigorous requirements for clinical evaluations and investigations. Devices must have a risk-benefit ratio established based on clinical evaluation data.
5. There are new technical documentation requirements for the Post Market Surveillance (PMS), Vigilance and Clinical Follow-up.
6. A documented strategy for regulatory compliance including compliance with conformity assessment procedure and management of modification to the devices covered by the system.
7. Manufacturers need to designate a person or group responsible for regulatory compliance – “responsible person”.
What devices are covered?
The MDR includes all devices previously covered under the MDD and AIMDD, except in-vitro diagnostic and some device combination products, which may be governed under other regulations. The MDR now includes some products without a medical purpose (e.g. coloured contact lenses).
REGULATORY COMPLIANCE
The MDR’s General Safety and Performance Requirements (GSPR) are very specific and require consideration of “the state of the art” when compared to similar devices, with specific emphasis on risk management especially as an ongoing activity throughout the product lifecycle. Manufacturers may need to update “technical files” or “design dossiers” to qualify their devices for CE Marking.
Changes to labelling will be required for most devices including covering UDI requirements. Up-classified devices may also require additional testing or clinical evaluation to achieve CE certification. Where legacy products may have been introduced before guidance reflecting current expectations were established, these products could require reassessment and possible re-testing to achieve certification to the MDR.
There is greater emphasis on clinical evidence to demonstrate the safety and effectiveness of devices for patient use, with additional changes to clinical investigations requiring medical device manufacturers to reference their clinical investigation plan.
OPPORTUNITIES FOR SUPPORT TO ACHIEVE COMPLIANCE
Each medical device manufacturer will be required under the MDR to evaluate the current state of their technical documentation and implement necessary changes to ensure compliance. This will include meeting all requirements of the MDR such as labelling, UDI and GSPR. Understanding the requirements for compliance with the MDR can be a significant challenge. VistaMed as part of the Freudenberg Medical group has extensive experience in design, development, validation, regulatory and quality and can support customers in achieving MDR compliance.
VistaMed has 20 years of experience designing, developing, and manufacturing finished medical devices and subassemblies, along with significant expertise in component extrusion technologies, catheter development and manufacturing. VistaMed has an integrated quality management system and lean programme (GROWTTH) which helps reduce costs, mitigate risk, streamline supply chain and ensure consistent quality.
Being part of the Freudenberg Medical group, VistaMed has global manufacturing capabilities and can support manufacturers on regulatory submission activities including 510k, Technical Files and Design Dossier compilations.
CONCLUSION
The EU Medical Device Regulation is required to be implemented by May 2020 and manufacturers should be working to ensure that their systems, processes and products are compliant. Non-compliance may lead to cessation of their rights to market the product in the EU.
VistaMed, as part of the Freudenberg Medical group, can support your effort in order to ensure compliance to the new MDR with technical expertise in areas such as design/redesign, validation/revalidation, testing, and significant expertise in the areas of regulatory submissions, technical file development/updates and design dossiers.
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About VistaMed
VistaMed is a leading provider of complex extrusions, finished catheters and devices to the minimally invasive medical device industry. We specialise in providing design and manufacturing expertise (from concept development to finished product) for a wide variety of extrusion and catheter based medical devices. VistaMed operates from three facilities with a team of over 400, operating in a combined work space of over 150,000sqft. www.vistamed.net