Translating your MDD to MDR submission
European medical device manufacturers must comply with MDR by May 2024
The Medical Device Regulation (MDR), which was in effect until May 2021, replaced the Medical Device Directive (MDD). 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 European Union created the MDD to harmonise medical device rules across Europe. To ensure that manufacturers legally sell medical devices in Europe, they must meet the MDD standards.
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. Manufacturers must recertify devices and update technical documentation and labelling to comply with new regulations.
MDR requires manufacturers to make many adjustments to product technical documentation and QMS procedures to comply. The new requirements are based on research and are substantially tighter than the MDD.
Manufacturers switching from MDD to MDR will need to assess their post-market expectations, risk management, and quality assurance procedures. MDD certificates were set to expire on 26 May 2024, and manufacturers should take action.
Translating your MDD to MDR submission
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. Notified Bodies must be involved in the procedure, which is still based on the device class (with the exception of Class I). NOTE – although still in place, this procedure has changed – see over the page.
- We still use harmonised standards to demonstrate conformance. However, the EU has also introduced the idea of “common specification”, see over the page.
- Medical device manufacturers from outside Europe can import their products, but they need an EU Authorised Representative.
What are the key changes for MDR?
The emphasis of the new regulation is on market unification. MDR reinforced some criteria, added other criteria, and removed none. 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 classified as at least Class IIa under MDR.
Quality Management System
- MDR has expended the QMS scope.
- This includes comprehensive requirements for Clinical Evaluation and Post Market Follow Up (PMCF).
- MDR regulation for Post Market Surveillance (PMS) is very detailed.
Notified Body Supervision
- Notified Bodies encompass more requirements than before.
- National Competent Authorities now control Notified Bodies 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.
- Manufacturers must carry out clinical trials on implantable medical devices and class III medical devices (with some exceptions). 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)
- The introduction of the UDI system has improved device identification and traceability.
- All manufacturers must assign a Unique Device Identification (UDI), consisting of a device identifier and a production identifier. This UDI must appear on all labels.
EUDAMED Database
- The EUDAMED Database is used to track devices throughout the economic operator supply chain.
- The database ensures that information about products and tests will be accessible to the public.
Equivalence
- MDR interprets equivalence much more thoroughly than the MDD. This will make demonstrating clinical safety or performance of medical devices more challenging.
Definition of medical device
- MDR broadens the medical device definition to include non-medical and cosmetic devices not previously regulated under the MDD.
General Safety and Performance Requirements (GSPRs)
- MDD Essential Requirements have been renamed ‘General Safety and Performance Requirements (GSPRs)’ and are significantly more specific than previously.
Technical Documentation
- Technical Documentation has replaced the Technical File or Technical Dossier.
- The Technical Documentation is more detailed and closely regulated than the MDD.
New Roles and Definitions
- Manufacturers must employ a suitable Person Responsible for Regulatory Compliance (PRRC).
- MDR defines Economic Operator roles, including Distributor, Authorised Representative and Importer.
Common Specifications
- The EU commission can establish “common specifications” (CS) if harmonised standards are inadequate to demonstrate conformance.
What are the responsibilities of a PRRC under the MDR?
Article 15(3) of the EU MDR outlines the requirements and responsibilities of the PRRC. The PRRC of a manufacturer is responsible for ensuring that:
(a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
(c) the post-market surveillance obligations are complied with in accordance with Article 10(10);
(d) the reporting obligations referred to in Articles 87 to 91 are fulfilled; NOTE: This refers to Vigilance reporting, i.e. serious incident, field safety corrective action, and incident trend reporting).
(e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued. NOTE: This statement confirms that the investigational device meets the General Safety and Performance Requirements in Annex I of the EU MDR, except those that relate to the clinical investigation and that precautions are taken to protect the subject’s health and safety.
Article 11(3) requires a PRRC of an authorised representative to ensure compliance with the requirements of the EU approved representative. The MDR also demands that the PRRC’s name and contact details be present in the EUDAMED database. The PRRC is responsible for ensuring compliance with the MDR but they are not required to fulfil all tasks and activities themselves.
CLIN-r+ Recommendations for a Compliant MDD to MDR submission
Manufacturers should review technical documents to ensure compliance with EU MDR requirements. We recommend a gap assessment, which is one of the most effective ways to achieve this.
- Manufacturers should reassess clinical data for any devices already on the market.
- We recommend that devices with insufficient data have additional testing conducted for recertification.
- Companies must establish strategies and review QMS to ensure regulatory compliance. We also recommend the implementation of clinical evaluation, safety, and risk management procedures.
- Manufacturers must have a Post Market Surveillance process in place and information collected, analysed and acted upon.
- You should review risk assessment 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!
Supporting an MDD to MDR transition
EU MDR Readiness Checklist
