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Medical Device Product Registration and Approval in European Union

​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

  • Other EU MDD 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 

  • Class I* (*sterile Is/ measure Im/ reuse Ir)

  • Class IIa

  • Class IIb

  • Class III

Class I being the lowest class while Class III being the highest class.

 

In IVDD, in vitro diagnostic medical device classification includes:

  • General IVD

  • 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:

  1. to identify the product intended use fall under which Directive/Regulation

  2. to determine the device classification

  3. to select the relevant conformity assessment procedure and quality assurance option based on the device classification

  4. to prepare the Technical Documentation (Technical File or Design Dossier) to demonstrate compliance with Essential requirement and Conformity assessment procedures.

  5. to appoint EU representative (EC rep) if legal manufacturer resided outside of EU

  6. to undergo the Conformity assessment by the EU notified bodyClass 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.

  7. 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.

Example of Approval

Source: TUV Rheinland

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