The new Medical Device Regulation (MDR) will come into effect on May 2020, after its initial approval and release in May 2017. The transition period of three years is, therefore, coming to an end soon. The new MDR’s purpose is to increase safety and efficiency. This system follows on the Active Implantable Medical Devices Directive (AIMDD) and the Medical Devices Directive (MDD). The transition from MDD to MDR can potentially pose a significant challenge to the medical device industry and industry bodies, manufacturers and certification bodies need to be aware of the new requirements.
What MDR can mean for companies and relevant bodies:
1. Longer time to place a product on the medical device market
The new MDR guidelines may mean that it will take longer to put medical devices on the market and keep it there.
2. All medical devices need to be re-assessed for compliance and certification
The new MDR requires all medical devices need to be re-assessed in order to ensure that they comply with requirements and certifications.
3. Higher pressure on notified bodies and competent authorities
MDR will potentially lead to an increased workload for notified bodies and the relevant authorities.
4. Rigorous post-market oversight
Post-market surveillance will be increased, with an increase in unannounced audits, product sample checks and product testing.
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5. Compensation for damage caused by defective medical devices
Patients will now be able to claim compensation for damage caused by defective medical devices.
6. A broader product scope
MDR will include a broader definition of medical devices and active implantable medical devices. The new definition will be expanded to include devices that do not have a medical intended purpose, such as cosmetic implant devices and materials. The scope of the regulation will also include devices designed for the purpose of ‘prediction and prognosis’.
7. Unique device identification
The MDR mandates the use of unique device identification mechanisms. This new requirement is expected to increase the ability of manufacturers and authorities to trace specific devices through the supply chain and facilitate prompt and efficient device recall.
The new certification has a few deadlines that medical device companies and certification bodies must be aware of:
According to article 120 Transitional Provisions:
- From 26 May 2020, any publication of a notification in respect of a notified body per Directives 90/385/EEC and 93/42/EEC shall expire.
- Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC prior to 25 May 2019 shall remain valid until the end of the period indicated on the certificate. Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC from 25 May 2019 shall remain valid until the end of the period indicated on the certificate, which shall not exceed five years from its issuance. They shall, however, expire at the latest on 27 May 2024.
For more information about MDR and the certification process, please contact DQS. DQS South Africa is your local business solutions partner, offering solutions that work for your sector. We form part of an international network dedicated to ensuring compliance and business conformity. For any questions about our services or to contact us, please visit dqs.co.za.