DIFFERENCE BETWEEN MDD 93/42/EEC AND

MEDICAL DEVICE RULES 2017/745

Challenges & Oppotnities
By
BUSINESS MANAGEMENT
CONSULTANTS INT’L
in collaboration with
Surgical Mfg. Association of Pakistan
WWW.BMCI.PK [email protected]
SHAUKAT ALI Cell. 0333-8612798
Regulatory and Management Consultant
 Sections

What’s New in MDR

Solutions

Questions / Problems & Solutions

Merger of 3 Directives into 2 Rules
Types of legislation

Constitution
Treaties/Intl Obligations
Executive Orders / Presidential Decrease
Case Laws / Common Law
Statutes/ Legislation

Regulations

Procedures and Code of Conduct

 Directives versus Regulations

Directives = Legislation ratified by the EU

Parliament and transposed into national
law by each Member State

MDR = “Direct entry into force” with clear and

defined rules that are binding across all Member
States
Key Changes
Timeline
Timeline
Timeline
 Important Dates
May 2017 • MDR published, the 3 year transition period begins
November 2017 • Notified Bodies can apply for designation
• MDCG installed
April 2018 • First Joint Assessment Audits for Notified Body designation performed
January 2019 • MDSAP certification of the QMS for manufacturers of Class II, III, and IV medical devices required for Canada2

• Transition deadline for ISO 13485:2016 in Europe

March 2019 • The United Kingdom (possibly) leaves the European Union, a transitional period may start (Brexit )
March 2020 • Eudamed goes live (however, there are provisions for delay)
• MDR becomes applicable and enforceable :
• All Class I, self-certified devices and custom-made devices (excluding Class III implantable) must be compliant
to the MDR
• Class I reusable surgical instruments, Class III implantable custom-made devices, devices new to MDR scope
(including Annex XVI), and devices up-classified from Class I self-certified must be certified by a Notified Body
May 2020 according to the MDR

• Combination products of a pharmaceutical and a medical device that are considered medicinal products must
comply with the General Safety and Performance Requirements, with notified body involvement if applicable

• Clinical investigations must comply with the MDR

• UDI must be added to technical documentation
• All PMS and PMCF requirements of the MDR apply, unless exempted by article 123
 Important Dates

May 2021 • UDI must be placed on the label of Class III devices that are MDR certified

• Certificates issued in accordance with Annex 4 of AIMDD and Annex IV of MDD that have not yet
May 2022
expired will become void

May 2023 • UDI must be placed on the label of Class lla and Class llb devices that are MDR certified

May 2024 • Other certificates issued under current Directives that have not yet expired will become void

• Devices that were CE marked under the MDD or AIMDD may no longer be marketed or put into
May 2025 service in Europe

• UDI must be placed on the label of Class I devices

 Difference Between MDD 93/42/EEC &
MDR 2017/745
Definitions
 Article 2 contains 71 definitions.
 MDD only contained 14
Classes
 In MDD 93/42 were 4 ( I,Is,Im,IIa,IIb,III)
 MDR-2017 Are 4 (I,Is,Ir,Im,IIa,IIb,III)
Safety
 The word "safety" appears 290 times in the
MDR. The MDD, by comparison, uses it only 40
times.
EU Definition of Medical Device (2017):
– Any instrument, apparatus, appliance, material or other article,
used alone or in combination with accessories or software,
intended for:
o Diagnosis, prevention, monitoring, prediction, prognosis,
treatment or alleviation of disease ..... or
 NEW - Does NOT necessarily have to
be therapeutic
EXAMPLE: Tinted contact lenses , Liposuction,Laser epilators,
o Electromagnetic field,Tatoo,
o Control or support of conception
Products for Cleaning, disinfection, or sterilization of medical
devices
– Does not achieve its intended action by pharmacological,
immunological or metabolic means, but may be assisted in
its function by such means
 Reusable Instruments by MDR-2017

'Reusable surgical instrument' means an instrument

intended for surgical use in cutting, drilling, sawing,
scratching, scraping, clamping, retracting, clipping or
similar procedures, without a connection to an active
device and which is intended by the manufacturer to be
reused after appropriate procedures such as cleaning,
disinfection and sterilisation have been carried out. (MDR
2017/745 Page 140/175)
NEW Regulatory Framework:
Known as Regulation (EU) 2017 / 745
– 175 pages
– 101 “Whereas” = WHY
– 10 Chapters of 123 Articles = WHAT
I: Scope and Definitions
II: CE Marking
III: Identification and Traceability
IV: Notified Bodies
V: Device Classification
VI: Clinical Evaluation
VII: Vigilance and Market Surveillance
VIII: Cooperation Among Member States
IX: Confidentiality, Data Protection, Penalties
X: Final Provisions
17 Annexes = HOW
 Comparison of Market Authorization for
Medical Devices

To achieve CE Mark, • To achieve clearance for

manufacturers submit a “substantially equivalent
to a Notified Body: device”, manufacturers
submit 510k application to
‒ Technical File required for FDA
Class I, IIa, IIb devices
‒ Design Dossier required for • To achieve approval for
class III medical devices a new medical device,
manufacturers submit
‒ Notified Body verifies whether PMA package to US FDA
medical device satisfies safety
and performance requirements
Key Changes
Key Changes (Summary of Safety & Clinical Performance SSCP)
Example of Key Change: Device Equivalence
“Equivalence” can only be established using a single,
CE-marked device that satisfies clinical, technical,
and biological requirements
 Example of Key Change: Device Equivalence
Manufacturer must confirm that any differences
between the device under evaluation and the
designated equivalent device does not affect
safety, performance, and clinical benefit

Equivalance not possible without agreement with predecessor

02 NOV 2017 AMWAAnnual Conference Orlando FR Cochran 27
Key Changes
Key Changes
 Reprocessing of single-use
devices

• in the absence of CS by 26 May 2020:

reprocessing and reuse of single-use devices
within a health institution or by an external re-
processor must be compliant with relevant
harmonised standards – subject to NB
certification (Article 17(5) MDR)
 Key Changes

EU REPRESENTATIVE
A LEGAL ENTITY = A COMPANY NOY
AN INDIVIDUAL ARTICLE-11
MUST HAVE DOCUMENTS
LIABILITY
 PRRC.

 PRRC = PERSON RESPONSIBLE

FOR REGULATORY OMPLIANCE IN
EACH MAUFACTURING UNIT.
Implantable Medical Devices

Joint replacement in Class III

Implantable Medical Devices Must
Go clinical trials
UDI SYSTEM ARTICLE-27
 Technical Documents
File Structure uniform (Guidline)
EU Agreement update
Product liability Insurance (If Putting
CE own)
Product Registration
Label Changes
IFU changes
Bar Code Accuracy
 UnAnnounced Audits

Un Announce Audit 5 years once

* Annexure IX Chapter 1 Section
3.4
Key Changes - Incident Reporting
 Manufacturers will need to report all
incidents, injuries and deaths into an EU
portal that will centralize relevant data so that
patients have access to more safety-related
information. Reporting for incidents that did
not result in death or serious deterioration in
health is moved to 15 days from 30 days.
 IVDs are now classified into four risk classes
that will require notified body review for about
90% of the devices, up from the current 10%.
 EUDAMED (Article 33)
European Databank on Medical Devices.
1. A public tool.
2. Expected to go live on March 25th, 2020 for an application
on May 26th, 2020.
3. Registration of Medical Devices and Certificates.
4. Unique Device Identification (UDI) database system,
5. Registration of Economic Operators.
6. Accreditation and designation data for notified bodies.
7. Vigilance and Post Market Surveillance (PMS) data.
8. Safety and Clinical summaries for medical devices and
IVDs.
9. Registration of clinical investigations
 PMS

PMCF MUST
POST MARKET SURVEYLANCE
REPORTS ARTICLE 86
 Impact/Challenges to SME
 Losing of CE certificates
 Losing of Business
 Losing Free hand in Class I and …
 Need Strictly implemented QMS ISO 13485
 Will Face frequent Audits from Customers
Limited Notified Bodies
Till Monday 30th July
Only 02 NB for MDR2017/745
NB0086 BSI UK and
NB0123 TUV SUD Germany
For MDD 59
In Year were 2012 (108)
Solutions
 Have Resources?

Plan And Go for Certification of

MDR 2017/745
 1. Assess Your Company
Strength,
Customer,
Product
2. Plan for Future
Budget
Product
Country
3. Make Joint Ventures (If Possible)
a. 2 or more company one platform
b. Customer Supplier Joint Venture
4 Lesson to Prepare fro EU
MDR-2017
1- Get the key stake holders engaged and set a
clear direction
2- Leverage your in house expertise.
a) Solicit input from experts ,ensuring you understand the
challenges associated with your compliance to EU
MDR
b) Company wise priority
c) Team for cohesive achievement.
3- Govern the Project Scope
4- Use focused assessment to inform and Improve your plans.
 At Least
Improve QMS
Improve Business
Slowly Make strength
Explore Other Markets
Proceed towards certification
Questions?