European Union and UK Medical Device Regulations

A manufacturer who is willing to manufacture, import, sell or distribute medical devices in the European Union (EU), should acquire or apply for relevant CE certification for that medical device. A CE mark accredits the medical device with the regulations laid and accepted by the EU and enables commercialization of the product in the European member states. In parallel, the manufacturer will be responsible for maintaining regulatory compliance QMS and making sure product is bearing the relevant CE mark.

EU Medical Device Regulation

Selection of a Notified body

For a medical device manufacturer, selecting the right Notified Body (NB) to begin commercialization of their products can be challenging. For a manufacturer based in one of the EU member states or located anywhere around the globe intending to manufacture, prepare for market access, enter, import, sell or distribute a medical device or IVD must identify the capabilities of the notified bodies.

Notified body assesses the product classification and design based on the parameters of safety, risk, and efficiency. It is a mandate that the medical device manufacturer should always align with the Quality Management System (QMS) and associated technical documentation during the course of commercialization.

How Athreva can assist medical device companies to select a Notifies Body:

  • Product classification as per EU guidelines
  • Identification of conformity assessment options
  • Identification of notified body and related requirements

Technical File Preparation

A company’s technical file or dossier consists of complete information regarding the design, function, composition, use, claims, and clinical evaluation of the medical device. Technical file or dossier is required for all the four (04) classes of devices (Class I, Class IIa, Class IIb, Class III depending on the usage and ‘Indications of use’ of the device).

Herein, Athreva can support you with:

  • Gap analysis of existing technical file and identification of applicable standards.
  • Clinical evidence reports and gap analysis.
  • Labelling & artwork

Product Registration/ Notification

The registration/notification of medical device poses manufacturers with significant challenges. EU’s regulatory requirements are continuously developed and evolved with time to meet consumer safety requirements. The perfect way to commercialize a medical device is not always easy to define and requires a wide range of expertise and experience. The CE mark enables free penetration of medical devices and IVDs within the European Union.

Athreva as a trusted partner offers high quality consultancy services to pave the way in EU for your company and the devices you manufacture. Our registration and notification services include:

  • Compilation of technical file for submission
  • Submission of technical file to competent authorities and follow-up
  • Registration on accessory regulatory portals
  • Scientific translation of technical file as per country specific requirements
  • Registration as per new EUMDR and MHRA guidelines (post Brexit)

Clinical Evaluation Reports (CER) and
Performance Evaluation Report (PER) for Medical Devices

If a manufacturer is planning to market a medical device in Europe, he must generate and maintain a Clinical Evaluation Report (CER) that complies with MEDDEV 2.7.1 revision 4 and the MDD or MDR 2017/745. Clinical evaluation report is a crucial step in the path to CE Marking. Manufacturers, at times, do not have the necessary expertise and/or experience to ensure that their device complies with European CER requirements. Athreva has expertise with CE regulations and clinical literature reviews to help manufacturers prepare a fully compliant CER. We help in authoring of CER and PER for medical devices and IVDs.

QMS Compliance Services

  • Gap analysis to identify the applicable standards
  • Support for establishing ISO 13485 quality system infrastructure
  • Support for audit co-ordination and query response for ISO 13485
  • Risk Management File- ISO 14971

Legal Representation/ Authorized Representation in EU

If a manufacturer does not have their physical location in Europe, they are required to appoint an EU authorized representative. Notified body requires appointment of an European Authorized Representative for the CE Marking process of medical devices. Compliance with the applicable directive is mandatory for any medical device or IVD placed in the EU market. If you do not have authorized representative, you cannot commercialize your medical devices and/or IVDs within the European Union.

Legal Representative

Why choose Athreva as your European Authorized Representative?

  • Having a registered presence in EU
  • Technical file documentation review
  • Support with adverse event reporting and audit preparation
  • Liaising with notified bodies during and post submission process
  • Pre-market notification for Class I and national registration of devices on behalf of a non-EU manufacturer

Medical Device Registration in UK

Post implementation of Brexit, the UK has left the membership of EU and lost ties to trade, administration and even regulations. Since there is a huge implication on medical device and IVD industries having to-and-fro business, the UK MHRA has granted a transition period after Brexit comes to an end after 31 December 2020.

Athreva team of professionals can consult manufacturers intending to sell, distribute or commercialize products in the UK post Brexit

With the onset of 01 January 2021, Medicines and Healthcare products Regulatory Agency (MHRA) will be fully responsible for defining and governance of UK medical devices market. This embarks new and swift shift from the current EU regulatory guidelines, and a manufacturer or a distributor needs to align with them, to continue commercialization.

  • The UK system governs and regulates medical device by:
  • - Defining medical device certified
    - Marking conformity requirements for a device
    - Releasing registration protocols for the devices with MHRA
Medical Device Registration in UK
  • Regulations are applicable for : Great Britain including England, Wales, and Scotland along with Northern Ireland.
  • Northern Ireland goes independent with variations in the regulatory purview post transition period.
  • Since UK, has granted transition period for devices certified by the European Economic Area (EEA)-based Notified Bodies, the manufacturers can continue commercialization of the products until 30 June 2023
  • Devices bearing a CE mark also continues to hold a position in the UK market until June 2023
  • A detailed go-to-market strategy will be released by the MHRA by January 2021

Athreva can assist non-UK based manufacturers in attaining a CE certificate and making their place in the UK market until the transition period. With our extended partnership, Athreva has its presence in the UK and can legally represent medical devices and IVDs in the UK.

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