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Europe - Regulation

The European Medical Devices Regulation (MDR) replaced the previous Medical Device Directive (MEDDEV), which was lagging the current state of the art. The MDR will be: 

  1. Introduced progressively 

  1. Updated regularly by means of Implementing Acts. 

  1. The existing MEDDEV Guidance Documents have been implemented into the text of Regulation. 

  1. Final version of the European Medical Device and IVD Regulations published on 5 May 2017 

  1. Europe Medical Device Regulation (MDR) 

  1. Europe In Vitro Diagnostic Regulation (IVDR) 

  1. MDD 93/42/EEC 

CONSOLIDATED Medical Device Directive (93/42/EEC) 

In-Vitro Diagnostic Devices Directive (98/79/EC)- Directive 98/79/EC on In Vitro Diagnostic Medical Devices 

The regulation of medical devices is primarily concerned with enabling patient access to high quality, safe and effective medical devices, and avoiding access to products that are unsafe. WHO has a mandate, as outlined in the World Health Assembly (WHA) Resolution 60.29 “to encourage member states to draw up national or regional guidelines for good manufacturing and regulatory practices, to establish surveillance systems and other measures to ensure the quality, safety and efficacy of medical devices and, where appropriate, to participate in international harmonization. The 67th WHA(World Health Assembly) approved the resolution “Regulatory system strengthening for medical products”. It states the importance of regulations for medical devices as one of the medical products, for better public health outcome and to increase access to safe, effective and quality medical products. New Medical Device Regulations have been introduced after the Covid-19 Pandemic and the IVDR will be fully applicable on 26 May 2022, after a five-year transition period. The MDR and IVDR represent a significant development and strengthening of existing regulatory system for medical devices in Europe and will replace the original Directives which have been in place for over 25 years. 

 

A notified body is an organization designated by an EU country to assess the conformity of certain products before being placed on the market. These bodies carry out tasks related to conformity assessment procedures set out in the applicable legislation, when a third party is required. The European Commission has published a list of such notified bodies. Manufacturers outside the EU must identify an EU-based authorized representative unless they have a registered business within the European Union. The primary task of the authorized representative is to be point of contact for the national health authorities of the Member States. Authorized representatives or manufacturers typically also register devices in individual member states. In the future, registration will become easier. With the Commission’s 2010 Decision to enforce use of Eudamed—the EU-wide database for devices on the market—registration of in vitro diagnostics in each country became redundant. 

Before placing a device, other than a custom-made device, on the market, the manufacturer shall, in accordance with the rules of the issuing entity referred to in Article 27(2), assign a Basic UDI-DI as defined in Part C of Annex VI to the device and shall provide it to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that device. 

Stage 1: Device Classification 

Medical devices are usually divided into subgroups. 

In Europe medical devices are divided into three different groups:  

  • Active implantable medical devices(AIMD), 

  • General medical devices and 

  • In vitro diagnostic devices (IVD).

Stage 2: Notification Procedure 

  • Member States may only designate conformity assessment bodies for which the assessment pursuant to Article 39 was completed and which comply with Annex VII. 

Stage 3: CE Marking 

Known as the “new approach” directives, these directives outline a set of “essential requirements,” rely on use of voluntary EU-wide harmonized standards and offer a choice of conformity assessment modules.

Presence of certain substances shall be labeled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging, with the list of such substances. Appropriate precautionary measures shall be given in the instructions for use (If the intended use of such devices includes treatment of children or treatment of pregnant or breastfeeding women or treatment of other patient groups considered particularly vulnerable to such substances and/or materials, information on residual risks for those patient groups). 

Serial No. 

Fee Type 

Amount/Pricing 

01. 

Marketing-authorisation application (single strength, one pharmaceutical form, one presentation) 

From €296,500 

02. 

Extension of marketing authorisation (level I) 

€89,000 

03. 

Type-II variation (major variation

€89,000 

04. 

Scientific Advice 

From €44,400-€89,000 

05. 

Annual fee (level I) 

€106,300 

06. 

Establishment of MRLs 

  • Identification of compliance requirements under various guidelines including all data requirements.​ 

  • Data gap analysis and pre-assessment support​ 

  • Technical documentation support​ 

  • Pre and post-submission support and technical liaison with authorities. 

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