MDR Certificate – Medical Device Certification

What is considered a medical device?

A medical device is defined as any instrument, apparatus, device, software, implant, reagent, material, or other article intended by the manufacturer to be used for human medical purposes. These include prevention, monitoring, diagnosis, treatment, or alleviation of diseases, compensation for injuries or disabilities, modification of the anatomy or physiological processes, or the provision of information through in vitro testing.

Medical device classification

• Class I – Includes non-invasive devices such as compression items, absorbent materials, and temporary-use surgical instruments. This class covers products not assigned to higher categories.

• Class IIa – Encompasses non-invasive devices like blood storage units and short-term invasive devices such as surgical tools used via body orifices, dental implants, and vital sign monitoring devices.

• Class IIb – Includes products such as blood bags, contraceptive devices, and disinfectants.

• Class III – Covers high-risk medical devices such as in vitro diagnostic tools, cardiac monitors, and implantable devices like breast implants and joint prostheses.

EU Regulation and MDR Certification

What is the MDR Regulation (EU) 2017/745?

On April 5, 2017, the European Parliament introduced the Medical Device Regulation (MDR) to enhance patient safety and unify regulatory frameworks across the EU. The MDR imposes stricter requirements for technical documentation, enhanced control procedures for high-risk devices, more thorough clinical evaluations, and a new product identification system known as UDI (Unique Device Identification). It also provides for patient compensation in case of defective products.

MDR implementation and transition periods

The MDR came into force on May 26, 2021, replacing the former Medical Devices Directive (93/42/EEC – MDD). Certificates issued by notified bodies under the old directives (90/385/EEC and 93/42/EEC) remain valid until:

• 31 December 2027 – For Class III and Class IIb implantable devices (excluding sutures, staples, dental fillings, dental crowns, screws, wedges, plates, wires, pins, clips, and connectors).

• 31 December 2028 – For other Class IIb, Class IIa, and sterile or measuring Class I devices.

During the transition, manufacturers can apply for new MDR certifications to replace existing MDD or AIMDD (Active Implantable Medical Devices Directive) certificates.

New classification rules under MDR

The MDR introduces new classification criteria based on usage duration, invasiveness, and reusability. The classification is determined by the manufacturer, and devices are grouped into:

• Class I

• Class IIa

• Class IIb

• Class III

Some devices may need to be reclassified into higher risk categories under the MDR.

What is the MDR Certificate?

The MDR (Medical Devices Regulation) is an EU regulation aimed at improving healthcare safety and product quality. Medical devices certified under the MDR by a notified body are proven to be safe, effective, and fit for purpose. Compliance with the MDR is essential for manufacturers seeking access to the EU market.

A compliant Quality Management System (QMS), aligned with ISO 13485, is required. This system should include risk management, corrective and preventive actions, management responsibilities, resource management, and supplier control. Manufacturers must maintain up-to-date technical documentation and ensure continuous compliance.

The MDR also mandates that manufacturers and authorised representatives retain technical files and EU declarations of conformity for at least 10 years after the last product is marketed – or 15 years for implantable devices.

Benefits of MDR Certification for Manufacturers

Achieving MDR certification offers significant advantages for medical device manufacturers:

• Faster market approval – Regulatory bodies can approve products more efficiently.

• Increased trust and credibility – MDR compliance demonstrates high-quality standards and lawful distribution.

• Simplified documentation requirements – Streamlined processes for product registration and quality assurance.

• Wider market access – Certified products can be distributed not only within the EU but also across the EEA and associated countries.

• Competitive edge – MDR certification signals product compliance, safety, and legal accountability, offering a strategic market advantage.

MDR Conformity Assessment Procedure

Before launching a medical device in the EU, manufacturers must complete a conformity assessment. For Class IIa, IIb, and III devices, this process involves a notified body. Class I products (except sterile, measuring, or surgical instruments) can be self-certified by the manufacturer.

Once conformity is established according to MDR, the product must bear the CE marking.

Distributors also have responsibilities under the MDR, including post-market surveillance, complaint registration, verifying UDI placement, and ensuring the presence of labels and instructions in the official language of the Member State.

Reminder on transitional provisions

Certificates issued before 25 May 2017 remain valid until the expiry date stated on the document. Devices certified or declared before 26 May 2021 can continue to be marketed during the extended transition:

• Until 31 December 2027 for higher-risk devices,

• Until 31 December 2028 for medium- and lower-risk devices.

Need more information?

If you have any questions or require assistance with MDR compliance, feel free to contact us at +48 22 292 40 24 or +48 505 16 03 03, or email us at Power@PowerRubber.com. You can also use our online contact form.