Translating your MDD to MDR submission

Translating your MDD to MDR submission

European medical device manufacturers must comply with MDR by May 2024

The Medical Device Directive (MDD), which was in effect until May 2021, was replaced by the Medical Device Regulation (MDR), which governs medical device production and distribution in Europe. By May 2024, European medical device producers must comply with the MDR. In this paper, we examine the main distinctions and what they imply for submissions.

?MDD vs MDR - Overview

The MDD was created with the goal of harmonising medical device rules across the European Union. The MDD standards must be met in order for manufacturers to lawfully sell medical devices in Europe.

On May 26, 2021, MDR took the place of MDD. The aim of MDR is to improve quality and safety requirements, making them consistent throughout all 27 EU member states (excludes the UK).

The MDD was substantially shorter and less comprehensive than the MDR. The demand for technical information transparency has increased due to medical device malfunctions, leading to safety, hygiene, and post-market surveillance playing a much greater role in the MDR.

Companies must evaluate their devices and core procedures in light of the new specifications. This necessitates devices be recertified, and technical documentation and labelling must be updated to comply with new regulations.

MDR requires manufacturers to make a number of adjustments to product technical documentation and QMS procedures in order to comply. The new requirements are based on research and are substantially tighter than those of the MDD.

Companies making the switch from MDD to MDR will need to assess their post-market expectations, risk management, and quality assurance procedures. All MDD certificates will expire on May 26, 2024 and manufacturers should start taking action immediately due to this pressing deadline.

?What remains unchanged from MDD?

Some concepts will remain unchanged from the MDD, such as:

??????????After completing a conformity assessment procedure, manufacturers continue to claim conformance with the CE mark. This is still based on the device's class and Notified Bodies must be involved in the procedure (with the exception of Class I). NOTE - although still in place, this procedure has changed – see over the page.

??????????Harmonised standards are still used to demonstrate conformance. However, the EU has also introduced the idea of "common specification", see over the page.

??????????Medical device manufacturers from outside of Europe are permitted to import their products, but they need an EU Authorised Representative; see over the page.

?What are the key changes for MDR?

The emphasis of the new regulation is on market unification. Some criteria were reinforced, other criteria were added, but none were removed. Examples include:

Medical Device Classification Rules

??????????The strictest rules will come into play for manufacturers of invasive devices. For example, those for implantation, surgeries, nanomaterials, substances introduced into the body and other active devices, including software.

??????????A new rule (11) specifically addresses software.

??????????Class I MDD medical devices face important changes and are now, under MDR, will be classified as at least Class IIa.

Quality Management System

??????????The QMS scope has been expanded.

??????????This includes comprehensive requirements for Clinical Evaluation and Post Market Follow Up (PMCF).

??????????Post Market Surveillance (PMS) is now regulated in great detail.

Notified Body Supervision

??????????The designation of Notified Bodies encompasses more requirements than before.

??????????Notified Bodies now find themselves controlled by National Competent Authorities and the European Commission.

An Independent Expert Panel

??????????MDR introduces a consultation procedure conducted by an independent expert panel for certain Class IIb devices (non-obligatory) and class III devices intended for implantation (obligatory).

??????????There is no procedure comparable to MDD Annex VI and all devices in classes IIa, IIb and III must now involve a Notified Body in the conformity assessment of a product for CE marking.

Clinical Evaluation Requirements

??????????The new MDR requirements include collecting clinical data from the literature already available and organising the clinical trials necessary.

??????????Implantable medical devices and class III medical devices (with some exceptions) must now be subjected to clinical trials. For all Class III and IIb devices intended to manage a drug (in or out of the body), the manufacturer may consult a group of EU experts to receive an opinion on the clinical development plan (CDP).

Unique Device Identification (UDI)

??????????A UDI system has been introduced to improve device identification and traceability.

??????????It is now required that all manufacturers assign a Unique Device Identification (UDI), which consists of a device identifier and a production identifier. This UDI must appear on all labels.

EUDAMED Database

??????????The EUDAMED Database will be implemented to help track devices throughout the economic operator supply chain and will be required on all labels.[CD1]?

??????????The database ensures that information about products and tests will be accessible to the public.

Equivalence

??????????This will be much more thoroughly interpreted than it had been previously. This will make demonstrating clinical safety or performance of medical devices more challenging.

Definition of medical device

??????????This will be broadened to include non-medical and cosmetic devices that were not previously regulated under the MDD.

General Safety and Performance Requirements (GSPRs)

??????????Essential Requirements have been renamed as ‘General Safety and Performance Requirements (GSPRs)’ and are significantly more specific than previously.

Technical Documentation

??????????The Technical File or Technical Dossier name has been changed to the Technical Documentation.

??????????The Technical Documentation is far more detailed and closely regulated than those of the MDD.

New Roles and Definitions

??????????Manufacturers must employ a suitable Person Responsible for Regulatory Compliance (PRRC).

??????????Other Economic Operator roles are defined including Distributor, Authorised Representative and Importer.

Common Specifications

??????????If harmonised standards are insufficient to demonstrate conformance, the EU commission can establish "common specifications" (CS).

?CLIN-r+ Recommendations for a Compliant MDD to MDR submission

??????????Manufacturers are advised to carry out a review of their technical documents to ensure compliance with EU MDR requirements. A gap assessment is one of the most effective ways of achieving this and we highly recommend.

??????????Any devices that manufacturers already have on the market, should have their clinical data reassessed.

??????????Any devices with insufficient data are recommended that additional testing be conducted for recertification.

??????????Strategies to ensure regulatory compliance should be established and a review of your QMS should be conducted. We also recommend the implementation of clinical evaluation, safety, and risk management procedures.

??????????Ensure you have a Post Market Surveillance process in place and information is being collected, analysed and acted upon.

??????????Risk assessment should be reviewed by gathering device performance data and comparing it to similar devices and threshold values.

??????????Communicate with relevant parties and Notified Bodies.

Clin-r+ provides expert assistance and has a wealth of experience to call upon. We can assist you with all the recommendations above to ensure you are MDR compliant. To learn more about our services and how we can help. Get in touch!