Understanding Europe's New
Medical Device Regulation - MDR 2017/745

COMPLIANCE DATES

• New MDR and IVDR regulations were approved in March 2017 by the European Council and in April 2017 by the European Parliament. Both regulations entered into force on May 26, 2017; new rules will apply starting May 26, 2020, for MDR, and May 26, 2022, for IVDR.

MDR NOVELTIES:

Overview of New Requirements

EU Regulation 2017/745 on Medical Devices

Structure of MDR – Fact Sheet

• Recitals 101

• Articles 123

• Annexes 17

Annexure :

• I General Safely and performance Requirements (GSPR)

• II Technical Documentation

• III Technical Documentation on PMS

• IV EU Declaration of conformity

• V CE Marking

• VI Registration and UDI

• VII Requirements for Notified Bodies

• VIII Clarification rules

• IX Full QMS and Technical documentation

• X Type Examination

• XI Product Conformity QA

• XII Certificates issued by Notified Bodies

• XIII Custom –made devices

• Xiv Clinical Evaluation and PMCF

• XV Clinical investigations

• XVI Products with no medical purpose

• XVII Correlation table with MDD

Information Pending

• Implementing / Delegated Acts (Art. 52)
  - Minimum frequency of unannounced audits & sample checks
  - (Annex IX) frequency and sampling basis of class lIa and llb technical documentation.
  - The physical, lab or other tests to be carried out by NBs for sample tests, assessment of technical documentation and type examination
  - For UDI, will be introduced over 1-5 years determined by product risk

• Common Specification (Art. 9)
  - General safely and Performance requirements
  - Technical documentation
  - Clinical evidence and post market follow up
  - Clinical Investigation
  - Devices without a medical purpose

Definition of Medical Device revised as follows:

• ‘Medical device’ means any instrument, apparatus, appliance, software implant regent, material or other article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
  - Diagnosis, prevention, prediction, prognosis, treatment or alleviation of disease
  - Diagnosis, monitoring, treatment, alleviation of or compensation for, an inquiry or disability
  - Investigation, replacement or modification of the anatomy or of a physiological or pathological process or state
  - Providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations.

And which does achieve its principal intended action by pharmacological Immunological or metabolic means in or on the human body, but which may be assisted in its function by such means.

MDR scope expands on MDD to include:

• Devices manufactured using tissues or cells of human origin or their Derivatives, which are, or are rendered, non-viable

• Devices for control or support of conception

• Product for cleaning, disinfecting or sterilising devices

• Device incorporating nano materials

• Invasive device re: body orifices, intended to administer medicines by inhalation.

• Substances applied to skin / introduced via a body orifice and absorbed or locally dispersed

• Active therapeutics with an integrated diagnostic function

• Products without an intended medical purpose : (aesthetic products) (annex XVI)
  - Contact lenses, fillers, equipment for removing/reducing/destroying adipose tissue/surgically invasive products to modify anatomy or fix body parts.
  - Equipment for brain stimulation by electric current, magnetic or EM fields to modify neuronal activity in the brain
  - Equipment emitting high intensity EM radiation for skin resurfacing. Tattoo or hair removal, other skin treatment

• Distance sales of diagnostic or therapeutic services (Art.6)

• Active implantable devices.

Out of scope:

• Specifically ATMP – Regulation (EC) 1394/2007

• Other products that contain or consist of viable biological material or viable organisms including living micro-organisms, bacteria, fungi or viruses in order to achieve or support the intended purpose of the product

• Food (EU) Regulation – 178/2002

Definitions:

• Accessory for a medical device: an article which, whilst not being itself a Medical device, is intended by its manufacturer to be used together with one or several particular medical devices to specifically enable the MD(s) to be used in accordance with its/ their intended purpose(s) or to specifically and directly assist the medical functionality of the medical Device(s) in view of its/their intended purpose(s)

• Intended purpose : the use for which a device is intended a/c the data supplied by the manufacturer on the label, in the IFU or promotional or Sales materials or statements as specified by the manufacturer in the clinical evaluation.

• Manufacture....Market the device under its name or trademark

Few examples of new requirements which are critical to the manufacturers’ are as follows in brief:

Technical Documentation

• Strategy for regulatory compliance

• Risk management plan per product

• Clinical evaluation plan
  - Clinical development plan

• Clinical Evaluation reports

• Summary of clinical safely and performance (SSCP) class III and implantables

• PMS plan including PMCF plan

• PMS report (Class I)

• Periodic safety update report (Class IIa, IIb, III)

• PMCF reports

A specific requirements for creating and updating information is relating to European Database on Medical Devices: “Eudamed”

• Secure, web-based portal, using an internationally recognised nomenclature, available free of charge, as a central repository for information exchange between competent authorities, the commission and other parties.
  - Different levels of access to NBs, economic operators, the public

• To improve transparency and availability of information

• To enable identification and traceability of device on the market

• Full, audited functionality due by 25 March 2020 (MDR Art. 34)

References in this article are taken from Author’s attending workshops and various articles/guidance/information available on the web. Special thanks to ‘Obelis’ EAR Services for inputs from their presentations. European Union website and their links provide detailed information on implementation.

** © European Union, [2018] Reuse is authorised provided the source is acknowledged.
The reuse policy of European Commission documents is regulated by Decision 2011/833/EU (OJ L 330, 14.12.2011, p. 39).

Specific details on various articles of MDR will be discussed in future series of articles like clinical evaluation requirements and clinical equivalence, PMCF, labelling, risk management, classification changes, UDI, conformity assessment, responsibilities of Importers, distributors, authorized representative, appointment of Person Responsible for Regulatory Compliance, notified bodies and their roles, DOC and like as per the various articles of MDR.

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