The European medical device industry is undergoing a transformative phase due to the enactment of the new Medical Device Regulation (EU MDR), which was officially signed on May 26, 2017. Unlike its predecessor, the Medical Devices Directive (MDD), the EU MDR is a regulation, signifying a binding legislative act across all EU member states. This mandates all medical device companies marketing their products in Europe to comply with the new set of standards outlined in the EU MDR.
The enforcement deadline for compliance was May 26, 2021. Post this date, companies failing to adhere to the EU MDR will be prohibited from selling their medical products within the European Union. The extent of the impact brought about by this regulation is substantial and varies based on your designation as an economic operator, be it a manufacturer, importer, authorized representative, or distributor.
This shift aims to bolster the assurance of medical device safety and effectiveness while fostering innovation and competitiveness within the European medical device market. The following guide aims to provide a clear pathway towards achieving compliance with the EU MDR, ensuring a smooth transition for all stakeholders involved.
Embark on a structured journey towards compliance with the new Medical Device Regulation (MDR EU2017/745) through our step-by-step guide. This guide is designed to provide a simplified understanding, aiding in efficient and cost-effective implementation of the new regulation.
Disclaimer: This guide is based on our experiences and should not be taken as professional advice.
Confirm if your Notified Body is MDR certified and supports your device scope. Find the list of all MDR-certified Notified Bodies including information on their scope under the following link.
Yes: Schedule your MDR audit date!
No: Transition to a certified Notified Body promptly.
Identify your role(s) as an economic operator(s) – Manufacturer, Importer, Distributor, or Authorized Representative, each having distinct MDR requirements.
Utilize our Economic Operators Tool for a clearer understanding of each role and its responsibilities.
Utilize our MDR Gap-Analysis Tool to:
Eliminate irrelevant information from the chapters and annexes.
Identify and filter out non-applicable keywords.
Review all requirements to determine their relevance to your business.
Prior to starting the implementation phase, you should put a plan in place. The steps below will guide you through the main topics. Do not forget to read MDR article 120 (transition period) carefully.
The main changes are:
EU MDR Transition Timelines (15th March 2023):
-until 31st December 2027 for Class IIb and III
-until 31ste December 2028 for Class I and IIa
-Until 26th May 2026 for Class III Implantable customer-made devices
-Extends validity of certificates issued up to 26 May 2021
-Remove “sell-off” date
These extended transition periods are intended to provide manufacturers with additional time to meet the new requirements of the EU MDR 2017/745. However, it’s important to note that these extensions apply only to certain medical devices, and manufacturers should carefully review the regulation to determine the specific deadlines applicable to their products.
During the transition period, devices that are compliant with the previously applicable Directives (AIMDD, MDD and IVDD) and devices that are compliant with the current Regulations (MDR and IVDR) can co-exist and may simultaneously be placed or made available on the EU market. This is particularly important for those third countries that rely on the CE marking of devices to grant access to their markets.
In conclusion, the transition period and deadlines for the EU MDR 2017/745 are critical aspects that manufacturers must understand and plan for. By doing so, they can ensure a smooth transition to the new regulatory framework, maintain market access, and ultimately ensure the safety and performance of their medical devices.
Source: Regulation (EU) 2023/607
4.1 Safety and performance checklist:
Our general safety and performance checklist stores the complete requirements of MDR annex 1.
4.2 Technical File:
Technical file update according to the MDR requirements.
4.3 Risk management according to ISO 14971:
Your risk management activities (plan, analysis, and report) should be aligned with your PMS and PMCF activities.
4.4 UDI System:
Each medical device needs a UDI-DI (Unique Device Identification – Device Identifier) and UDI-PI (Unique Device Identification – Production Identifier) and must be submitted and transferred to the UDI database. (See document from the EU Commission)
MDCG 2018-1 v3: Guidance on basic UDI-DI and changes to UDI-DI
MDCG 2018-2: Future EU medical device nomenclature – Description of requirements
MDCG 2018 Rev.1: Guidance on UDI for systems and procedure packs
MDCG 2018-4: Definitions/descriptions and formats of the UDI core elements for systems or procedure packs
MDCG 2018-5: UDI assignment to medical device software
MDCG 2018-6: Clarifications of UDI related responsibilities in relation to article 16
MDCG 2018-7: Provisional considerations regarding language issues associated with the UDI database
MDCG 2019-1: MDCG guiding principles for issuing entities rules on basic UDI-DI
MDCG 2019-2: Guidance on application of UDI rules to device-part of products referred to in article 1(8), 1(9) and 1(10) of Regulation 745/2017
4.5 Post Market Surveillance (PMS):
Post market surveillance is defined in chapter VII of the MDR.
4.6 Post Market Clinical Follow-Up (PMCF):
Manufacturers shall conduct a clinical evaluation in accordance with the requirements set out in Article 61 and Annex XIV, including a PMCF. We have prepared a PMCF-Plan template.
4.7 Clinical Evaluation:
According to MEDDEV 2.7.1 Rev.4.
MDCG documents for clinical investigation and evaluation:
MDCG 2019-9: Summary of safety and clinical performance
MDCG 2020-5: Guidance on clinical evaluation – equivalence
MDCG 2020-6: Guidance on sufficient clinical evidence for legacy devices
MDCG 2020-7: Guidance on PMCF plan template
MDCG 2020-8: Guidance on PMCF evaluation report template
MDCG 2020-10: Guidance on safety reporting in clinical investigations
MDCG 2020-13: Clinical evaluation assessment report template
Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. The particulars on the label shall be indelible, easily legible, clearly comprehensible to the intended user or patient.
4.9 EUDAMED registration:
EUDAMED is now online but not all six modules are fully functional. It can be expected that the EUDAMED will be fully functional around 2029. More detailed information about EUDAMED and how it works can be found in our following blog post.
MDCG document for EUDAMED:
MDCG 2019-4: Timelines for registration of device data elements in EUDAMED
MDCG 2019-5: Registration of legacy devices in EUDAMED
MDCG 2020-15: Position Paper on the use of the EUDAMED actor registration module and of the single registration number (SRN) in the Member States
4.10 Common Specifications:
Take care about upcoming specification updates. We keep you informed with our Regulatory Intelligence Paper. Furthermore, this paper helps to address regulatory activities according to ISO 13485:2016, Chapter 5.6 Management Review.
Performing internal audits and a final mock audit to ensure the key requirements have been implemented.
The Final checklist will ensure the completeness of your implementation process.