Current EU Directives
Since 1990s, medical Device in Europe is regulated by the following three directives:
Active Implantable Medical Device Directive (AIMDD 90/385/EEC)
Medical Device Directive (MDD 93/42/EEC)
In Vitro Diagnostic Medical Device Directive (IVDD 98/79/EC)
New EU Regulations
On 25 May 2017, the two new Regulations came in force and will supersede the 3 Directives:
European Medical Device Regulation (MDR 2017/745), with 3 years transition until effective on 26 May 2020
In-vitro Diagnostic Medical Device Regulation (IVDR 2017/746), with 5 years transition until effective on 26 May 2022
EU MDD/AIMDD/IVDD directives and guidances. Click here
List of EU Notified Bodies. Click here
Under Article 120 (2) of Regulation (EU) 2017/475 on MDR and (EU) 2017/746 on IVDR, certificates issued in accordance with the three Directives will remain valid latest until 27 May 2024.
Under Article 120 (3) of second Corrigendums to Regulation (EU) 2017/475 on MDR, Class I medical device under AIMDD and MDD will remain valid until with declaration of conformity was drawn up prior to 26 May 2020 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, or which has a certificate that was issued in accordance with AIMDD and MDD, remain valid until 26 May 2024.
Note: Validity remains with certain obligations still applicable under the new regulation such as economic operators, no significant change to product intended use, vigilance reporting still applicable.
Useful CE information
EU Medical Device/IVD regulations and corrigendums. Click here
Latest EU MDR guidances. Click here
List of EU Notified Bodies. Click here
European Competent Authorities for Medical Devices. Click here
MDR and IVDR Transitional FAQs. Click here
MDR/IVDR Roadmap. Click here
Joint Action on Market Surveillance of Medical Devices (JAMS). Click here
Topics details. Click here
Custom-made devices under MDR Article 52(8) and annex XIII - procedure for custom-made devices
EUDAMED register. EUDAMED details.
Competitiveness of enterprises and small and medium-sized enterprises (COSME) finance programme
In-house or home brew medical device in healthcare institutions and laboratories
Innovative Medicines Initiative (IMI) programme to speed up innovative medicines for patient access
Common Nomenclature for Device (CND), which mapped GMDN to support the function of EUDAMED
Notified Body. European Notified body list
Software and apps, refer to MEDDEV 2.1/6 'Guidelines on the qualification and classification of stand-alone software used in healthcare within the regulatory framework of medical devices'. Dedicated requirements have been set for medical software, apps, cybersecurity.
Unique device identification (UDI) in Article 27 of the 2017/745 and Article 24 of Regulation 746/2017, consist of UDI-DI (Device Identifier) and UDI-PI (Production identifier), storage of UDI and UDI database. Decision (EU) 2019/939 of 6 June 2019 with 4 issuing entities designation including GS1, HIBCC, ICCBBA, IFA.
Countries exiting European Union eg UK (Brexit) and Switzerland.
Medical Device & IVD Classification
In both MDD and MDR, medical device classification includes:
Class I* (*sterile Is/ measure Im/ reuse Ir)
Class I being the lowest class while Class III being the highest class.
In IVDD, in vitro diagnostic medical device classification includes:
Self Testing IVD
Annex II List B IVD
Annex II List A IVD
General IVD being the lowest class while List A IVD being the highest class.
In IVDR, in vitro diagnostic medical device classification includes:
Class A IVD
Class B IVD
Class C IVD
Class D IVD
Class A being the lowest class while Class D IVD being the highest class.
Steps to CE marking by the Legal Manufacturer
Before the medical device can be marketed and supplied in the European market, the manufacturer must affix the product with CE conformity mark by undergoing conformity assessment to demonstrate the device has met the essential requirements defined in the applicable directives.
The manufacturer has:
to identify the product intended use fall under which Directive/Regulation
to determine the device classification
to select the relevant conformity assessment procedure and quality assurance option based on the device classification
to prepare the Technical Documentation (Technical File or Design Dossier) to demonstrate compliance with Essential requirement and Conformity assessment procedures.
to appoint EU representative (EC rep) if legal manufacturer resided outside of EU
to undergo the Conformity assessment by the EU notified body. Class I medical device, General IVD and Class A IVD however does not require to be assessed by the Notified Body and only required Manufacturer self-declaration of Conformity.
to affix the CE mark on the product after Manufacturer issued the CE Declaration of Conformity and additionally after received EU Notified body's CE certificate for those undergone the EU Notfied body conformity assessment.
Consultancy by ARQon
ARQon provides services on:
Regulatory Strategy for step 1 to 3 above
Regulatory compliance technical documentation preparation, advisory, internal audit for item 4 and 6
EU representative (EC Rep) service for item 5
ARQon team has also involved actively with the manufacturer, in the product life cycle from the product design and development to product commercialization.