Explanatory note on MDR codes

Medical Device Medical Device Coordination Group Document MDCG 2019-14

MDCG 2019-14 Explanatory note on MDR codes

December 2019

This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission. The document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission. Any views expressed in this document are not legally binding and only the Court of Justice of the European Union can give binding interpretations of Union law.

Explanatory note on MDR codes

1 Introduction

Commission Implementing Regulation 2017/2185 establishes the codes for the designation of notified bodies in medical devices under Regulation (EU) 2017/745 and in vitro diagnostic medical devices under Regulation (EU) 2017/746. These codes are primarily used by designating authorities to define the notified body scope of designation but they are also used by the notified body to:

1. 1) describe the individual qualification of the NBs staff members
2. 2) describe the qualification required for assessing a device These codes may be very broad and, furthermore, unequivocal authorisation of personnel to codes and the assignment of codes to a device is not always straightforward. However, the notified body’s system needs to ensure, in all cases, that the authorisation of personnel and team allocation for the conformity assessment of a device ensures adequate knowledge and expertise.

2 Scope

The lists of codes and corresponding types of devices established by the above mentioned Regulation takes into account various device types which can be characterised by design and intended purpose, manufacturing processes and technologies used, such as sterilisation and the use of nanomaterials. These lists of codes should be used in a way that provides for a multi-dimensional application to all typology of devices. This will ensure that notified bodies as well as the staff assigned to conformity assessment are fully competent for the devices they are required to assess. This guidance is intended to explain the different level of codes and how they should be used, including the use of conditions with a view to ensure a harmonised use of the codes especially for the allocation of resources to conformity assessment activities.

3 Assignment of codes to devices within the conformity assessment procedure

When a manufacturer lodges an application with a notified body, the type of devices and technologies subject to conformity assessment activities are to be indicated. Usually, at the application review stage (as defined in section 4.3 of Annex VII MDR), notified bodies will verify the assignment of codes provided by the manufacturer or will assign these codes to the devices themselves. This verification is carried out in order to ensure that the notified body is able to assess the application based on its designation, and that it has available resources to carry out the relevant conformity assessment activities (feasibility evaluation). Thefinal assignment is made by the NB. After this application review, and signing of the contract, the notified body will allocate appropriately qualified and authorised personnel to carry out audit activities or product reviews. The following table presents an overview of the different types of codes and a summary of the main characteristics of each of them for the assignment to specific devices and the allocation of resources. Type Code Assignment of codes to the device Relevance for allocation of conformity assessment team

MDA / MDN

Codes reflect design and intended purpose of device Exactly 1 code per device.

The codes should be selected according to their hierarchical order in Regulation 2017/2185. If more than 1 MDA/ MDN code is applicable, the one that is highest in the list should be selected. Allocation of personnel involved in the review of technical documentation (e.g. product reviewers) or in audits concerning product related aspects. MDS Horizontal codes that reflect the specific characteristics of the device

0 to several per device

Assign all codes applicable to the device.

Select once an MDN/MDA code has been assigned. Allocation of personnel involved in the review of technical documentation (e.g. product reviewers of sterilisation validation).

May also be applicable to staff performing audits concerning certain special processes (e.g. sterilization).* MDT Horizontal codes that describe technologies or processes

1 to several per device

Assign the codes which describe the main production technologies or processes.

Select once an MDN/MDA code has been assigned. Allocation of personnel involved in audits (e.g. site auditors involved in the auditing of metal processing). * Note: Assessment of these codes could be performed by Product reviewers or Site auditors depending on their competence

3.1 MDN / MDA-codes

MDA / MDN-codes reflect the design and intended purpose of the device and hence are mostly relevant for the allocation of personnel involved in the review of technical documentation. In some specific cases, the NB may assign product reviewers to assess product performance and safety aspects during an audit. This means that if there are product related issues to be audited and the auditors do not possess the required qualification, product reviewers who are qualified for the device in question should be part of the audit team. The NB needs to ensure that the personnel allocated to the project are competent to assess for the devices and technologies under assessment . Special attention should be paid in situations such as the one described in example 4 of this section.

The MDA / MDN codes may either specify a field of medical application (e.g. MDA 0309 Active non-implantable ophthalmologic devices) or the physical or technological principle of the device (e.g. MDA 0302 Active non-implantable devices utilising non-ionizing radiation or MDA 0315 Software). Therefore, there are cases where more than one specific code might apply to a device (e.g. surgical laser for refractive surgery of the eye ). Also, where there is a broad intended purpose, several codes may apply. Having these issues in mind, when drafting the Regulation 2017/2185, the codes were put in order such that the MDA/MDN codes that require very specific technological knowledge and experience are highest in the code lists. Therefore, in cases where more than one MDA/MDN code apply, the code highest in the list is to be selected. This approach ensures consistent assignment of codes (and therefore consistent assignment of suitably qualified staff) to devices. Example 1: A surgical laser for refractive surgery of the eye is assigned to MDA 0302 Active non-implantable devices utilising non-ionizing radiation and not to MDA 0309 Active non-implantable ophthalmologic devices because, even though both codes are specific for the device, since MDA 0302 is higher in the list. Example 2: A screw for orthopaedic surgery is assigned to MDN 1102 Non-active osteo- and orthopaedic implants and not to 1104 Non-active soft tissue and other implants, because MDN 1102 is higher in the list. Devices may be composed of different “components” which, if they were products on their own, would belong to different MDA/MDN codes (1). In such cases, the intended purpose or the main physical or technological principle of the device should be considered (Example 3). Nonetheless, the notified body needs to ensure that the assigned staff is qualified to assess all components of the device. Example 3: A medical devices is composed of a suture anchor (a bone screw attached to a surgical suture to reattach ruptured tendons) as well as a single use deployment instrument and a single use bone drill. The components are provided sterile in a blister, are covered by the same technical documentation and are not available individually (e.g. are not medical devices on their own). This product is assigned to MDN 1102 Non-active osteo- and orthopaedic implants and not to MDN 1208 Non-active non-implantable instruments because the implanted component of the device is associated with the intended purpose rather than the deployment instrument and the drill. Note that, given the complexity and the diversity of medical devices, in exceptional cases deviations from the guidance given above may be necessary when assigning codes to devices in order to ensure suitably qualified staff in the conformity assessment. In such cases, a brief rationale shall be documented (see Example 4). Example 4: A heater-cooler unit (HCU) for cardiac surgery is a device through which blood circulates, and which changes the circulating blood’s temperature in order to achieve hypo-or hyperthermia. Both the codes MDA 0303 Active non-implantable devices utilising hyperthermia/hypothermia and MDA 0306 Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis are specific to the device. Since MDA 0303 Active non-implantable devices utilising hyperthermia/hypothermia is a code that describes physical or technological characteristics higher in the list, according to the rule explained above MDA 0303 should be chosen. Nonetheless, the notified body assigns the device to the code MDA 0306 Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis and documents that the risks associated with the HCU are such that the staff having experience in this code is more suitable to assess the device. It is important to note that Stand-alone software (i.e. software that is not part of a physical medical device) should be assigned to MDA 0315 since assessment of software requires very specific knowledge (see annex VII 3.2.2 5th indent MDR) and also that non-implantable cardiovascular

1 This description does NOT refer to procedure packs or systems according to MDR Article 2 (10) and (11) since those are combinations of individual CE-marked products that have been subjected to separate conformity assessments.

catheters, guidewires, introducers, filters and related tools shall fall under MDN 1203 (instead of MDN 1201 or MDN 1202).

3.2 MDS codes

MDS codes are horizontal codes that are applicable to devices with specific characteristics. All codes that are applicable need to be assigned to a device in order to ensure that the review team possesses the full set of qualifications necessary for the conformity assessment. The MDS-codes are mainly relevant for the allocation of personnel involved in the review of technical documentation. This is because, generally, the auditing aspects linked to MDS codes have their corresponding MDT code for the relevant technology (e.g. MDS 1001 Devices incorporating medicinal substances vs MDT 2007 Devices which require knowledge regarding the production of pharmaceuticals). However, MDS codes may also be applicable to staff performing audits concerning certain special processes (for example MDS 1005 for staff auditing ethylene oxide sterilization processes). Example 1: A partially resorbable, sterile surgical implant that contains an antibiotic to prevent post-surgical infection will need to be assigned to the following MDS codes:

1. 1) MDS 1005-Devices in sterile condition: because it is provided sterile,
2. 2) MDS 1008-Devices utilising [...] being wholly or mainly absorbed or locally dispersed in the human body [...]: because it is absorbed, and
3. 3) MDS 1001-Devices incorporating medicinal substances: because it contains an antibiotic. Example 2: An infusion pump should be assigned to MDS 1009-Devices incorporating software/utilising software/controlled by software [...] because the infusion pump is controlled by software.

3.3 MDT codes

MDT codes relate to the technologies and processes that are used in the manufacturing and making available of the devices. MDT codes are relevant for the allocation of site auditors. Assignment of MDT codes should be done taking into consideration production of the device itself as well as for critical upstream production steps. This means that, even though many codes could be applicable when taking into consideration the processes involved in the entire supply chain of a medical device, these should not be considered for the use of MDT codes (e.g. for an electronic medical thermometer, at one point, metal processing, plastic processing, non-metal mineral processing, chemical processing, manufacture in clean rooms, manufacturing using electronic components, labelling and packaging are necessary to assemble the device from raw materials). Example 1: An electronic medical thermometer for layman’s use should be assigned to the following MDT codes:

1. 1) MDT 2010 Devices manufactured using electronic components including communication devices because the product is assembled from electronic components and
2. 2) MDT 2011 Devices which require packaging, including labelling because the device is packed and labelled. Example 2: A sterile animal derived bone graft substitute is manufactured using several steps. In the first step, the raw animal bone undergoes a sequence of chemical treatments to remove organic components. In a second step, the remaining mineral bone component is subjected to a heat treatment, then ground and sieved to obtain particles of defined sizes. The material is packed, labelled and sterilized. Therefore the following MDT codes should be assigned:

1. 1) MDT 2008 Devices manufactured in clean rooms and associated controlled environments, because the manufacturing of the implant after the heat treatment is conducted in clean rooms,
2. 2) MDT 2009 Devices manufactured using processing of materials of human, animal, or microbial origin because the implant is made from animal bone
3. 3) MDT 2011 Devices which require packaging, including labelling because the implant is packed and labelled.

1. 1) MDT 2008 Devices manufactured in clean rooms and associated controlled environments, because the manufacturing of the implant is in a controlled environment,
2. 2) MDT 2006 Devices manufactured using chemical processing, because the main risks in manufacturing are related to the testing and mixing of the components,
3. 3) MDT 2011 Devices which require packaging, including labelling because the implant is packed and labelled. Example 4: A manufacturer of cross-linked hyaluronic acid implants has no in-house manufacturing. The finished, labelled implant is bought from a supplier. The implant raw material (hyaluronic acid) is produced by fermentation using bacteria. The following MDT codes should be assigned:
4. 1) MDT 2008 Devices manufactured in clean rooms and associated controlled environments, because the manufacturing of the implant is in a controlled environment,
5. 2) MDT 2005 Devices manufactured using biotechnology, because the main risks in manufacturing are related to the production and cross-linking of the hyaluronic acid.
6. 3) MDT 2011 Devices which require packaging, including labelling because the implant is packed and labelled. Note that, despite the fact that the manufacturer itself does not physically manufacture the device, the MDT codes concerning the manufacturing steps are assigned to the device since they are relevant when auditing suppliers / subcontractors.

4 Competence description: conditions (including limitations)

Conditions should be established by the notified body for individual codes in cases where the qualification of the staff authorised to a certain code is not sufficient to cover the entire spectrum of the devices within this code. The designating authority could also apply conditions to the notified body's designation where the notified body does not have sufficient competence to cover a given code or could seek designation for conformity assessment of only certain devices within a code. Conditions, including limitations, should be formulated in an unambiguous way (see example 1). Furthermore, since the technical codes basically mirror the competence system of the notified body, the conditions and limitations should concern device characteristics (see example 2). Example 1: “MDN 1101 Non-active cardiovascular, vascular and neurovascular implants. Condition: heart valves”. This condition is unsuitable since it is not clear whether the notified body is restricted to assessment of heart valves or whether those products are excluded from

the scope of designation. Therefore, the condition should be “excluding heart valves” or “including only heart valves”. Example 2: “MDN 1102 Non-active osteo- and orthopaedic implants. Condition: excluding class III devices”. The scope of designation is intimately linked to the qualification of the staff that the notified body needs to have available. Conditions serve to exclude the devices for which the notified body does not have competent staff and/or suitable procedures; therefore, they need to be expressed in a way that they relate to knowledge and experience of staff and/or procedures. The condition “excluding class III devices” does not allow this and therefore it is unsuitable. In this case, the designating authority has to determine, based on the qualification of the notified body’s staff, which devices are included in the scope. This might result, for example, in the following condition: “including only orthopaedic plates and screws; excluding implants that are applied in or on the spine”. Further examples of conditions are illustrated in the final column of the table below. Considerations of the conditions should be based on the demonstrated competence of the applicant body .

5 Specific clarifications linked to individual codes

The devices included in the third and fourth columns are only a few examples of the devices covered in the relevant code. The third column is not intended to provide an exhaustive list of devices included in each code.

MDA CODE Active implantable devices Devices covered and Specific Considerations1 Examples of conditions MDA 0101 Active implantable devices for stimulation / inhibition / monitoring Implanted defibrillator Spinal cord stimulator Implantable cardiac pacemakers Implantable bladder stimulators Excluding brain stimulation MDA 0102

Active implantable devices delivering drugs or other substances Implanted drug delivery pump

MDA 0103

Active implantable devices supporting or replacing organ functions Artificial heart Cochlear implants

MDA 0104

Active implantable devices utilising radiation and other active implantable devices Prostate radioactive seed implant

1 The assessment also should consider Section 5.1 of Annex IX applies as well as Validation of SSCP acc. Article 32.

MDA CODE Active non-implantable devices for imaging, monitoring and / or diagnosis Devices covered and Specific Considerations Examples of conditions MDA 0201

Active non-implantable imaging devices utilising ionizing radiation X-ray computer tomography equipment Gamma cameras Fluoroscopy equipment PET scanner Restricted to X-ray and gamma cameras MDA 0202

Active non-implantable imaging devices utilising non-ionizing radiation MRI computer tomograph

MDA 0203

Active non-implantable devices for monitoring of vital physiological parameters Blood pressure monitor Medical thermometer Pulse oximeter Apnoea monitors Intensive care patient monitoring system Spirometers Electrocardiographs Electroencephalographs

MDA 0204

Other active non-implantable devices for monitoring and / or diagnosis Ocular tonometer Audiometers Retinal cameras

MDA CODE Active non-implantable therapeutic devices and general active non-implantable devices Devices covered and Specific Considerations Examples of conditions MDA 0301

Active non-implantable devices utilising ionizing radiation

Radioactive sources for cancer after loading therapy Therapeutic cyclotrons and linear accelerators

MDA 0302

Active non-implantable devices utilising non-ionizing radiation Surgical laser for refractive surgery of the eye Laser for pain treatment

Including only microwave and magnetotherapy medical devices MDA 0303

Active non-implantable devices utilising hyperthermia / hypothermia Medical heating blanket

Warming and cooling blankets Blood warmers Paraffin bath

MDA 0304

Active non-implantable devices for shock-wave therapy (lithotripsy) Extracorporeal shock wave lithotripsy device

MDA 0305

Active non-implantable devices for stimulation or inhibition

Automated external defibrillator Device for the transcranial magnetic brain stimulation Device for transcutaneous electrical nerve stimulation (TENS) Muscle stimulators Electrical acupuncture External bone growth stimulators

MDA

Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis Haemodialysis machine and equipment Cardiopulmonary bypass pump Infusion pumps Feeding pumps Jet injectors for vaccination Blood pumps for heart-lung machines Anaesthesia machines

MDA 0307

Active non-implantable respiratory devices

Medical ventilator Hyperbaric chambers Nebulisers

MDA 0308

Active non-implantable devices for wound and skin care

Water jet for wound debridement

MDA 0309

Active non-implantable ophthalmologic devices

Aspiration pump for opthalmological use (removal of crystalline residue) MDA 0310

Active non-implantable devices for ear, nose and throat

Hearing aids

MDA 0311

Active non-implantable dental devices

Powered dental surgical unit and hand pieces Surgical suction device for dental use Ultrasonic scalers Chairs with equipment

MDA 0312

Other active non-implantable surgical devices

RF electrosurgical generator Electrosurgical instrument Cauterization devices. Powered surgical drills and saws

MDA

Active non-implantable prostheses, devices for rehabilitation and devices for patient positioning and transport Hospital beds Patient hoists Electric Wheelchairs Active limb prostheses Exoskeletons

MDA 0314

Active non-implantable devices for processing and preservation of human cells, tissues or organs including in vitro fertilisation (IVF) and assisted reproductive technologies (ART) IVF cryopreservation systems blood bank refrigerator MDA 0315

Software

Radiotherapy planning system.

MDA 0316

Medical gas supply systems and parts thereof

Medical gas supply system in a hospital Gas manifold and line pressure regulator for medical regulators Medical gas supply pipeline systems

MDA 0317

Active non-implantable devices for cleaning, disinfection and sterilisation Sterilizers like autoclaves etc Washer disinfector for medical devices. MDA

Other active non-implantable devices

MDN CODE Non-active implants and long term surgically invasive devices Devices covered and Specific Considerations Examples of conditions MDN 1101

Non-active cardiovascular, vascular and neurovascular implants Cardiac vascular stent Peripheral vascular stent Artificial heart valve Cardiac Valve Prostheses, Vascular and neurovascular grafts, shunts, vascular stents, cardiovascular patches Sutures for cardiovascular surgery For biological heart valves MDS 1003 should be applied. For drug eluting stents-MDS 1001 should be applied Including only cardiac stents MDN 1102

Non-active osteo- and orthopaedic implants

Artificial spinal disc Spinal cage Bone graft substitute for orthopaedic indications Prosthetic joint replacements (i.e knee, hip implants) Bone cement Hyaluronic acid implant for intra-articular use Orthopaedic nails, screws,plates Bone graft substitute for maxillofacial indications sutures, suture anchors, staples for orthopedic surgery spacers, ligament reconstruction products

For antibiotic bone cements-MDS 1001 should be applied For absorbable substances MDS 1008 should be applied

MDN

Non-active dental implants and dental materials

Dental implant Dental fillers Root canal filler Abutments

MDN

Non-active soft tissue and other implants

Hyaluronic acid dermal fillers Intraocular lenses Intrauterine dispositive-IUD Breast implant Hernia mesh Urethral stent implants Sutures (not falling within the above codes) Eyelid implants

Bariatric surgery devices: Intragastric Balloons, Gastric Bands, Anti-Reflux implants. Lung Volume Reduction devices: Coils, Valves, Sealants. Biliary and Pancreatic stents

For contraceptive intrauterine devices containing copper or silver – MDS 1001 should be applied

Excluding breast implants MDN CODE Non-active non-implantable devices Devices covered and specific conditions Examples of conditions MDN 1201

Non-active non-implantable devices for anaesthesia, emergency and intensive care Device for pleural drainage Masks, tubes for the administration of gases. Endotracheal tube Tracheostomy tubes Endotracheal tube introducers

MDN

Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis Intravenous line Hypodermic needle Syringe tubing, bags for injection or transfusion Dialysis filter Dialysis solution Epidural catheters, Urinary Catheter Amnioscopic needles

MDN 1203

Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools Vascular filter catheter Embolectomy catheter Cardiovascular guidewires and catheters Neurovascular catheters central venous catheter.

MDN 1204

Non-active non-implantable devices for wound and skin care

Wound dressing Cotton wool Gauze dressings Bandages Sutures for dermal wound closure (of less than 30 days) Surgical gloves For dressings incorporating an antimicrobial agent-MDS 1001 should be applied

MDN 1205

Non-active non-implantable orthopaedic and rehabilitation devices Orthoses Crutches Wheelchairs

MDN

Non-active non-implantable ophthalmologic devices

Contact lenses Eye drops Instrument for ophthalmologic surgery Solutions for contact lenses.

MDN 1207

Non-active non-implantable diagnostic devices Thermal expansion thermometer MDN 1208

Non-active non-implantable instruments

Instruments for general use in surgery: Forceps, clamps, scalpels, dental instruments

MDN 1209

Non-active non-implantable dental materials

Etching solution for dental use Braces Dental cements (when not considered long term surgically invasive) Dental impression materials

MDN 1210

Non-active non-implantable devices used for contraception or prevention of the transmission of sexually transmitted diseases Condom Contraceptive diaphragms

MDN 1211

Non-active non-implantable devices for disinfecting, cleaning and rinsing Solutions for disinfecting medical devices Contact lens care, catheter lock solutions

MDN 1212

Non-active non-implantable devices for processing and preservation of human cells, tissue or organs including in vitro fertilisation (IVF) and assisted reproductive technologies (ART) Freezing solution for egg cells Embryo transfer catheters Artificial insemination probes Media, substances or mixture of substances intended for washing, separating, sperm immobilizing, cryoprotecting solutions.

MDN

Non-active non-implantable devices composed of substances to be introduced into the human body via a body orifice or the dermal route

MDN 1214

General non-active non-implantable devices used in health care and other non- active non-implantable devices Ultrasound gels

MDS CODE Devices with specific characteristics Devices covered and specific conditions Examples of conditions MDS 1001

Devices incorporating medicinal substances

Devices incorporating medicinal products including herbal substances and human blood derivatives are included in this code.

MDS 1002

Devices manufactured utilising tissues or cells of human origin, or their derivatives Section 5.3.1 of Annex IX applies MDS 1003

Devices manufactured utilising tissues or cells of animal origin, or their derivatives Section 5.3.2 of Annex IX applies Devices manufactured utilising tissues or cells of animal origin, or their derivatives, which are non-viable or rendered non-viable, unless such devices are intended to come into contact with intact skin only

MDS 1004

Devices which are also machinery as defined in point (a) of the second paragraph of Article 2 of Directive 2006/42/EC of the European Parliament and of the Council1

MDS 1005

Devices in sterile condition Including aseptic processing, ethylene oxide gas sterilisation (EOG), low temperature steam, formaldehyde sterilisation, moist heat sterilisation, radiation (gamma, x-ray, electron beam), sterilisation with hydrogen peroxide, sterilisation with liquid chemical sterilising agents, thermic sterilisation with dry heat

1 Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast) (OJ L 157 9.6.2006, p. 24).

MDS

Reusable surgical instruments

Reusable surgical instruments according to art. 52 (7) c) MDR

MDS 1007

Devices incorporating or consisting of nanomaterial

MDS CODE Devices with specific characteristics Devices covered and specific conditions Examples of conditions MDS 1008

Devices utilising biologically active coatings and / or materials or being wholly or mainly absorbed or locally dispersed in the human body or are intended to undergo a chemical change in the body Section 5.4 of Annex IX applies for devices intended to be introduced into the human body via a body orifice or applied to the skin and devices at are systemically absorbed by the human body in order to achieve their intended purpose

MDS 1009

Devices incorporating software / utilising software / controlled by software, including devices intended for controlling, monitoring or directly influencing the performance of active or active implantable devices

MDS 1010

Devices with a measuring function

MDS 1011

Devices in systems or procedure packs

MDS 1012

Products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745

MDS

Class III custom-made implantable devices

MDS

Devices incorporating as an integral part an in vitro diagnostic device

MDT CODE Devices for which specific technologies or processes are used Examples of device manufacturing technologies MDT 2001 Devices manufactured using metal processing

3 d printing, Casting, Welding

3d printing (metal), turning (metal), anodization, passivation, polishing, surface modification, laser tube cutting, honing MDT 2002 Devices manufactured using plastic processing

Injection molding, Extrusion, Bonding polymer compounding, 3d printing (plastics), thermoforming, blow moulding, turning (plastics)

MDT 2003 Devices manufactured using non-metal mineral processing (e.g. glass, ceramics) Ceramic sintering, ceramic compounding,

MDT 2004 Devices manufactured using non-metal non-mineral processing (e.g. textiles, rubber, leather, paper) Weaving, knitting MDT 2005 Devices manufactured using biotechnology

Fermentation using cell cultures, enzymatic production processes, purification and modification of biomolecules MDT 2006 Devices manufactured using chemical processing

Compounding, buffering MDT 2007 Devices which require knowledge regarding the production of pharmaceuticals production, handling and incorporation into a device of substances which, if used separately, can be considered to be a medicinal product MDT 2008 Devices manufactured in clean rooms and associated controlled environments MDT 2009 Devices manufactured using processing of materials of human, animal, or microbial origin Handling, dissection, storage, processing, inactivation and sterilization of human and animal tissues

MDT 2010 Devices manufactured using electronic components including communication devices

MDT

Devices which require packaging, including labelling

MDT

Devices which require installation, refurbishment

Installation of devices at the point of use by or under the manufacturer’s responsibility MDT

Devices which have undergone reprocessing