Embracing MDR is not merely about meeting regulatory standards; it is about enhancing product quality, patient safety, and bolstering the reputation and competitiveness of your devices in a rapidly evolving market.
The Medical Device Regulation (MDR) was published in the European Union (EU) Official Journal in April 2017 and entered into force on May 26th, 2021, with a transition period of 3 years before it became mandatory (May 26th, 2024). Since then, the transitional period for certain MDD (Medical Device Directive) products has been extended according to the amendment to Regulation (EU) 2017/745:
- May 26th, 2026 specifically for Class III implantable custom-made devices.
- December 31st, 2027: for higher-risk devices, including class III medical devices and class IIb implantable medical devices; with the exception of sutures, staples, dental fillings, orthodontic appliances, screws, wedges, plates, wires, pins, clips and connectors.
- December 31st, 2028: for medium and lower-risk devices, including class IIb devices (other than those mentioned above), IIa and I.
It's crucial to note that this extension comes with certain conditions. Only devices deemed safe, and for which manufacturers have already taken substantive steps –as applying to a Notified Body to transition to the rules outlined in the Medical Devices Regulation, will benefit from the additional time. The appropriate Surveillance must be guaranteed for the devices.
The application of the extended transition period is subject to several conditions, such as:
- The devices must continue to comply with Directive 93/42/EEC, as applicable. This condition is already part of the current Article 120(3) MDR.
- The devices do not undergo significant changes in the design and intended purpose. This condition is already part of the current Article 120(3) MDR.
- The devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health. The concept of “unacceptable risk to health and safety” is set out in Article 94 and 95 of the MDR.
- No later than 26 May 2024, the manufacturer has put in place a quality management system (QMS) in accordance with Article 10(9) of the MDR. This condition aims to ensure that manufacturers gradually move towards full compliance with the MDR requirements.
- No later than 26 May 2024, the manufacturer, or its authorised representative, has lodged a formal application under the MDR.
- No later than 26 September 2024 the notified body and the manufacturer have signed a written agreement.
Key changes with the new MDR
The aim of the new MDR was to address some inherent weaknesses in the old directives as well as the swift evolution of science and technology in the field of medical devices. To do so, it introduced several key improvements, among them:
- More strict 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 reinforcement of the criteria for designation and processes for oversight of Notified bodies
- 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 manufacturer
- Improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance
Source: ec.europa.eu
Medical devices compliant with the MDD on the market after 26 May 2021 must be compliant with the Article 120(3) of the MDR.
From 26 May 2021
- The device continues to comply with the Directive.
- There are no significant changes in the design or intended purpose.
Furthermore, the requirements in the MDR related to the following shall apply:
- Post-Market Surveillance [Article 83-86, 92, Annex III]
- Market Surveillance [Article 93-100]
- [Article 87-92]
- Registration of economic operators and devices [Article 31 and 29]
The Amending Regulation (EU) 2023/607 allows the MDD certificates to be recognised as valid beyond the dates indicated on the certificate if certain conditions set out in the Amending Regulation are met.
Intertek Medical Notified Body
Medical Device certification under the Medical Device Regulation MDR (2017/745) is offered through our legal entity Intertek Medical Notified Body AB (IMNB AB), Notified Body Number NB 2862.
The headquarters for IMNB AB is in Stockholm, Sweden. We continue to have our teams based around the globe, including but not limited to North America, China, India, United Kingdom, and Sweden.
Frequently Asked Questions (FAQ)
The MDR is the European Union Medical Device Regulation 2017/745 that were released in 2017 which essentially govern the clinical investigation, design, development, production, sales, and distribution of medical devices in Europe. The MDR applies since 26 May 2021, it repeals Directive 93/42/EEC (MDD) on medical devices and the Directive 90/385/EEC on active implantable medical devices.
The aim of the MDR is to address some inherent weaknesses in the old directives while assuring reliability, safety and innovation in the field of medical devices. Compared to the MDD, MDR introduces more emphasis on the life-cycle approach to medical devices.
There are much higher demands on manufacturers. Generally, Conformity assessment procedures by the Notified body are more complex. Product equivalence will be more stringently interpreted. Clinical data and Clinical Evaluation Report (CER) will face heavy scrutiny and require frequent updates. Manufacturers must also fulfill increased post-market surveillance requirements, perform more Post-Market Clinical Follow-up (PMCF) studies, and deliver Period Safety Update Reports (Class IIa devices and above). Transitioning to the MDR might seem overwhelming and many companies don’t know where to start. The process will require certain capacity, financial investments, and strengthen expertise by the manufacturers.
- The first step is to assess your current level of compliance. A thorough gap analysis will generate a task list for updating your procedures and documentation.
- Make sure your marketing claims are covered by clinical data.
- Portfolio assessment should be carried out to determine which products you want to transition and invest in.
- Check the ability of your Notified Body of serving you with MDR certification, in time for the full applicable scope of your devices.
- Check if the Classification of your devices will change. Manufacturers need to determine whether new conformity assessment routes are now applicable to their product portfolio.
- Make sure that you have full technical documentation for all devices you market including the post-market clinical data as part of the on-going assessment.
- Make sure IT processes ready. MDR might also be an opportunity to upgrade tools and systems. Manufacturer to make sure there is a process for the UDI requirements and keep an eye on the developments and requirements for EUDAMED.
Related Articles
Useful Resources
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Best Practice Guidance for the Submission of Technical Documentation under MDR (PDF)
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IMNB AB & IMNB UK Ltd Declaration of Impartiality 2023 -2024 (PDF)
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European Commission - Medical Devices (health.ec.europa.eu)
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Intertek Medical Notified Body Standard Fees (PDF)
Please Note
If you are a client and have a current MDD certificate(s) with us, these will remain under SEMKO AB NB 0413 until that certificate expires, unless you are specifically notified otherwise.
Intertek Business Assurance does not provide consulting services for management systems certification. Any consulting activities provided by Intertek are separated and independent from testing and certification activities and undergo a regular detailed risk analysis to ensure impartiality is maintained.
