The European Medical Device Regulations - analysis of the final text

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European Medical Device Regulations
(MDR)
Analysis of the final text

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• The European Medical Device Regulations (MDR) replace the previous Medical
Device Directive (MEDDEV), which was lagging behind the current state of the
art.
• The MDR will be
• Introduced progressively
• Updated regularly by means of ‘Implementing Acts’
• The existing MEDDEV Guidance Documents have been implemented into the
text of the Regulation.
Background

Timeline
April 2017
Adoption of MDR
June 2017*
Entry into Force (EUOJ + 20 days)
June 2020*
Date of Application
June 2025*
End of MDD/AIMD sell-off stock period
Transition period
3 years
Restricted MDD/AIMD
Certificate Validity (4 more years)
MDD/AIMD certificates (max. 5-year expiration from issue/renewal date)
NBs re-designation under MDR
MDR Certificates
June 2022*
Annex IV certificates expire
June 2024*
MDD/AIMD certificates expire
Source: NAMSA *dates are estimates based on current
understanding of the process & steps

Overview

The previous directive only covered products with a medical purpose.
The new regulations also cover the following:
• Contact lenses with no corrective action
• Implants for modification or fixation of body parts
• Facial or other dermal or mucous membrane filler
• Equipment for liposuction, lipolysis or lipoplasty
• Invasive laser equipment intended to be used on the human body
• Intense pulsed light equipment
• Products specifically intended for the cleaning, disinfection or sterilisation of medical devices
and devices for the purpose of control or support of conception
Scope expansion

Medical Device Coordination Group (MDCG)
• Providing support for borderline decisions, CTSs, clinical investigations, vigilance,
appointment of NBs
• Ensure harmonised interpretation and practice
• Made up of members appointed by the Member States based on experience in the field of
medical devices and chaired by the Commission.
New Committees

Assessment Committee for Medical Devices (ACMD).
• Provides scientific advice on medical technology, regulatory status of devices and other
aspects of implementation of this Regulation
• Clinical experts in relevant medical fields for medical device being assessed, at least one
representative of the EMA and one from patients' organisations
• Meets on request from the MDCG or the Commission, chaired by a Commission
New Committees

Supervision of Notified Bodies (NB)
• NB to be checked annually by their Competent Authority (CA), including unannounced
inspections, including subcontractors and including subsidiaries
• Every second year, the check includes a representative from a CA from a country other than
the supervising CA
• NB submits annual reports to CA, Commission who passes them to MDCG
• Fees levied on NB by the CA must be proportional and consistent with the standard of living,
be transparent and made public
• In conjunction with MDCG, Commission ensure good functioning of NB coordination group
which must meet at least 2 times per year
• For Class III devices, the NB surveillance shall check parts & materials and where
appropriate, reconcile purchases with manufactured devices
Notified Bodies

Assessment of Notified Bodies
• All current NBs will need to be re-certified under the new Regulation
• NBs shall have permanent in-house administrative, technical and scientific personnel, with
medical, technical and where needed, pharmacological knowledge
• Notified bodies shall make publicly available the list of subcontractors or subsidiaries, the
specific tasks for which they are responsible and the declarations of interest of their
personnel
• NBs wishing to be appointed as conformity assessment bodies will be assessed by at least
1 person from the Commission, one person from a different Member State and as a
‘special’ NB, EMA is included
Notified Bodies

EUDAMED expansion
• To accommodate registrations for medical devices, manufacturers (SRN), Authorised
Representatives and importers, certificates, incident reports, and market surveillance
measures
• Information split: publically available vs. restricted access
• UDI information to ensure traceability within the internal market
• Registration of NBs, subcontractors, subsidiaries and annual reports
• Applications for clinical investigations and outcome of trials
• Summary of safety performance for high risk devices
• Post market surveillance and corrective action
European Database for Medical Devices
(EUDAMED)

• Every manufacturer’s organisation is required to have a qualified person
responsible for regulatory compliance
• Qualifications and experience are stipulated
• Responsibilities include:
• Conformity of devices prior to release
• Technical documentation and Declaration of Conformity are up to date
• Vigilance and market surveillance is carried out as required
• Ensuring for investigational devices that the signed statement, that the device meets
general safety and performance requirements, is available
• Authorised Representatives are also required to have at least one qualified
person for regulatory compliance
Person responsible for regulatory
compliance

• Familiar terms with previous ER
• No possibility to perform a normal risk benefit ratio for products with no medical
benefit. Other risks need to be considered in those cases.
• IFUs
• Implant Card (ex: sutures, staples, dental implants, screws, plates)
• UDI
• ER checklist not required however needs to be revised/reformat with new
Requirements
• Harmonised standards still a great reference tool for presumption of conformity
• Common Specifications (CTS for IVDs) directly published by the EC
Safety and Performance requirements
(Annex 1)

Medical devices or parts that are invasive or come into contact with the body of
patients, or (re)administer medicines, body liquids, gases or other substances,
to/from the body, or transport or store medicines, body fluids, gases or
substances, to be (re)administered to the body, shall not contain Phthalates that
• Are carcinogenic, mutagenic or toxic to reproduction, in accordance with Regulation (EC)
No 1272/2008, in concentrations above 0,1% by weight or are endocrine disruptors
• Are endocrine disruptors
Potentially Harmful Substances

Classification and conformity
assessment

• As the Active Implantable and Medical Device Directives have now been
combined in the proposed Regulation, all Active Implantable Devices, and their
accessories, fall under Class III
• European Commission can intervene into Class III conformity assessment by reviewing
Notified Bodies/Manufacturers evaluation on clinical data + Post Market Clinical Follow-up.
• Exception = CE Certification extension & CS existing for addressing clinical evaluation for
type of device
• In case of diverging opinions on classification between Member States, they
will be referred to the Medical Device Coordination Group
Classification Changes

Implants
• For custom made implants = Notified Body intervention
• IIb implants closer to class III assessment
• Higher scrutiny to class III implants
Classification Changes

Classification changes
Rule 2 Blood bags previously under rule 18
Rule 3 IVF products under class III
Rule 6 Reusable surgical instruments have become class IIa devices
Rule 8 Active implantable devices or accessories are Class III
Breast implants are Class III
All joints replacements (expansion) are Class III
Orthopaedic implants moved to Class III
Rule 19 Devices containing nano particles are in Class III
Rule 20 All devices intended to be used for aphaeresis are Class III
Rule 21 Substances to be inhaled or administered rectally of vaginally, that are absorbed or
dispersed, are in Class III

• IVDs are placed into 4 classes, based on risk: A (lowest risk), B, C and D (highest
risk)
• Class A IVDs will largely be CE marked without involvement of the NB, unless they can be
used for near patient testing, contain a measuring function or are sterile. Then the NB will
check these specific aspects.
• Class B, C and D IVDs require an appropriate level of NB involvement
• Class B & C – the NB checks the quality management system
• Class C – additionally, the NB checks the technical documentation
• Class D – specific approval of the Design Dossier & QMS before release
IVD classification

Conformity assessment
Class I
Technical Documentation
Annex II
DoC (Annex III)

Custom made
Technical Documentation - Annex XI
PMS/PMCF/Incidents - Annex XIII
Identification of healthcare
institution/prescription/patient & Annex I
Market access

Class III Implantable Custom made
Technical Documentation -Annex XI
QMS (Annex VIII) / Production QA
( Annex X)
Identification of healthcare
institution/prescription/patient &
Annex I

Class Is/Im
Annex II
- QMS (Annex VIII)
- Production QA ( Annex X)
DoC (Annex III)

Class IIa
Annex II – Level of sampling?
- QMS (Annex VIII)
- Production QA ( Annex X/A)
- Product Verification (Annex X/B)
DoC (Annex III)

Class IIb Technical Documentation Annex II
Annex VIII - implantable
Annex IX – Type examination
- QMS (Annex VIII)
DoC (Annex III)
No design dossier review for the class IIb
active devices that transport medicines to
and from the body

Class III
Annex VIII
Annex IX – Type examination
- QMS (Annex VIII)
!! Consultation - 2001/83/EC, 2004/23/EC,
722/2012/EU for devices includiing medicinal
substances, human/animal tissue
!! EC expert panel consultation -
Annex VIII/IX for implantable devices
DoC (Annex III)

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The European Medical Device Regulations - analysis of the final text