The European medical device industry will undergo significant changes as a result of the new medical device regulation which has signed on May 26th, 2017. As the name suggests, is it a regulation and no longer a directive and all medical device companies that sell medical products in Europe have to adhere to this new regulation.
Companies that do not follow this regulation will no longer be allowed to sell their medical products in the European Union after May 26th, 2021. Depending on your role as economic operator (manufacturer, importer, authorized representative, distributor) the impact can be meaningful.
Below you will find a step-by-step implementation guide with regards to the new medical device regulation (MDR EU2017/745). Our guide is simple to understand and will allow you to save time and money when implementing the new regulation.
(Note: This guide should not be considered as a recommendation, it’s just based on our own experiences.)
Will your Notified Body be certified by MDR and also support your device scope?
Yes: Save your MDR audit date!
No: Change your Notified Body as soon as possible!!!
In a first step you should check the new MDR rules if they have any impact on your existing or future product classification. See MDR Annex XIII or use our classification form.
Depending on your business you may have one or multiple economic operator responsibilities, which is imperative to know before you start with the gap assessment. Economic operators are Manufacturers, Importers, Distributors or Authorized Representative. Each of them has different requirements to fulfill per the MDR.
Our Economic Operators Tool will help you to get a better understand of each operator and what their responsibilities are.
Reduce not required information by going through the chapters and annexes and eliminate all not required information.
Define keywords which are not applicable to you. In our MDR tool you have the opportunity to search for these keywords.
Go through all open requirements step by step and define if requirements are relevant for your business or not.
We also can help you through the first steps with our MDR STARTING PACKAGE. We show you how our tool works and give you some extra helpful documents which are not available on our page. These extra checklists and tips will speed your IVDR project dramatically.
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
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:
Currently, the EUDAMED is not online but a first FUNCTIONAL SPECIFICATION version is available. The initial release was March 2020, but the European Commission has decided to change the initial release up to May 2022 (see decision letter). Any changes to the release date will be communicated with our Regulatory Intelligence Paper.
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.