The Medical Device Regulation (MDR) will replace the MDD on 26 May 2020. Medical device legal manufacturers are now in various stages of addressing the many changes implied by the new European Regulation. Main changes are product scope expansion, reclassification of devices, more rigorous clinical evidence, recertification of currently approved devices and the use of unique device identification.
This also includes establishing and maintaining quality system requirements for third parties involved in the design, manufacture, inspection or testing of the product or any components used therein. In other words, electronic contract manufacturers are directly concerned and will play a huge role in helping OEMs implement these changes. Valtronic helps customers be compliant by producing devices of high quality and with highest reliability and traceability.
Why is the MDR so challenging for medical device Legal Manufacturers?
MDR not only concern future product certifications but also requires recertification of all currently approved devices. Therefore, Legal Manufacturers must review the specifications of all their products to verify their conformity. Documents and processes will have to be adapted, as well as some products in order to be compliant with the new regulation. The task is huge since changes also include establishing and maintaining quality system requirements for suppliers involved in the design, manufacture, inspection or testing of the products. Legal Manufacturers must ensure that their most critical suppliers, i.e. those with the greatest impact on the conformity of finished devices, are fully compliant and prepared for unannounced audits. Thus, supply continuity depends on a suppliers’ compliance with regulations. Resulting in regulatory compliance being a key criterion for the choice of a contract manufacturing partner.
Valtronic is ISO 13485:2016 certified and has over 35 years of experience in the medical device market. Our product portfolio includes active implants which require high quality and traceability. We understand the requirements of the new European Regulation and have a proven QMS in place with thorough documentation, which helps our customers in ensuring the new MDR certification for their products.
How will the MDR impact the European medical device market?
With the new MDR, the burden for placing a medical product on the market will become even longer than before, impacting timelines. Focus will now be on the entire product lifecycle, requiring greater clinical evaluation before approval. This will undoubtedly slow device submission significantly. So, working on improving the efficiency of any step of the production process will help to not increase that time more.
How Valtronic helps you optimize your time to market
Thorough documentation is, as previously mentioned, an important factor to facilitate the certification of medical devices. A Contract Manufacturer can support you in many other ways to optimize time to market despite the new challenges resulting from the MDR. Valtronic knows what your needs and obstacles are and helps you at every stage of the development and manufacturing process.
Here are a few examples:
- When designing your device, our R&D team does it with manufacturing in mind, which includes BOMs elaborated with qualified suppliers
- At Valtronic, prototypes are built on real production lines and thus very close to your final device. A real asset for feasibility studies and tests, and finally a great help in mitigating risks when transitioning to first series and then clinical studies. Risk mitigation in early stages of your product development can avoid iterations and rework towards certification, helping you reduce time to market.
Partner with the Right Contract Manufacturer
As a conclusion, choosing a Contract Manufacturer who understands your needs and obligations is more than ever key to ensure compliance with tight Regulations and above all, high quality products that will improve patients’ lives with the lowest risk possible.
What is the MDR and what are the main changes for medical device OEMs?
(Source: TÜV Sud)
The EU’s Medical Device Regulation (MDR) was officially published on 5 May 2017 and came into effect on 25 May 2017. The MDR will replace the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC).
Product scope expansion –
The definition of medical devices and active implantable medical devices will be expanded to include devices such as colored contact lenses and cosmetic implant devices and materials. Devices designed for the purpose of “prediction and prognosis” of a disease or other health condition will also be included in the scope.
Implementation of unique device identification
The MDR mandates the use of unique device identification (UDI) mechanisms. This requirement is expected to increase the ability of manufacturers and Authorities to trace specific devices through the supply chain, and to facilitate the prompt and efficient recall of medical devices that have been found to present a safety risk. In addition, the European Databank on Medical Devices (Eudamed) is expected to be expanded to provide more efficient access to information on approved medical devices.
Rigorous post-market oversight
The MDR increased post-market surveillance authority by the Notified Body. Unannounced audits, along with product sample checks and product testing will strengthen the EU’s enforcement regime and help to reduce risks from devices that may be unsafe. Annual safety and performance reporting by device manufacturers will also be required in many cases.
Reclassification of devices
The MDR requires device manufacturers to review the updated classification rules and update their technical documentation accordingly by considering the fact that Class III and implantable devices will have higher clinical requirements and a regular scrutiny process.
More rigorous clinical evidence for Class III and implantable medical devices
Device manufacturers will also be required to collect and retain post-market clinical data as part of the ongoing assessment of potential safety risks.
Systematic clinical evaluation of Class IIa and Class IIb medical devices
Manufacturers will need to re-prepare their clinical evaluation by considering the new wording of the regulation on an equivalence approach and under which circumstances it is possible to justify not conducting a clinical investigation.
No “grandfathering” provisions
Under the MDR, all currently approved devices must be recertified in accordance with the new requirements. Exemptions are under negotiation right now.