Medical Device Compliance FAQs
Should Original Equipment Manufactures obtain CE Marking?
Obtaining the CE Marking provides a great strategic advantage for any manufacturer! This is true whether you are an Original Equipment Manufacturer (OEM) or an Original Brand Labeler (OBL).
If you are an OEM manufacturer, obtain your own CE Marking today!
Does the NEW RoHS 2011/65/EC Directive Apply to Medical Devices?
The recast of the Restriction of Hazardous Substances (RoHS) Directive was published in the official journal of the European Commission on the 8th of June 2011 as 2011/65/EU.
With the exception of the items listed in Article 2.4, the RoHS Directive applies to all Electrical & Electronic Equipment.
Medical devices (under 93/42/EEC) and IVD devices (per 98/79/EC) are now included. They are both part of the general group called ‘medical devices’ in the directive. Active implantable medical devices (under AIMDD 90/385/EEC) remain excluded from the scope of the 2011/65/EU.
The maximum concentrations in homogenous materials are limited, by weight, to the following:
Lead (0.1 %)
Mercury (0.1 %)
Cadmium (0.01 %)
Hexavalent chromium (0.1 %)
Polybrominated biphenyls (PBB) (0.1 %)
Polybrominated diphenyl ethers (PBDE) (0.1 %)
Devices must bear a CE marking and have a declaration of conformity for the RoHS Directive from:
- 22nd of July 2014 for Medical Devices.
- 22nd of July 2016 for In-Vitro Diagnostic Medical Devices.
NOTE: A single CE marking and declaration are acceptable. (You will need to explain the dual meaning of the CE marking in the instructions for use and clarify that, if used, the Notified Body number only applies to the MDD or IVDD related issues.)
- Means any natural or legal person established within the European Union who has received a written mandate from a manufacturer to act on their behalf in relation to specified tasks (RoHS 2011/65/EU Article 2.7);
- A Non-EU manufacturer (not having a registered address in the EU) will be required to nominate an Authorized Representative in order to obtain the CE marking.
- Cables and spare parts needed for the repair or reuse of devices may continue to be distributed for devices placed on the market prior to the transition date.
- Exemptions available to all devices are listed in Annex III. Specific exemptions for medical devices are listed in Annex IV.
- Exemptions for medical devices will be valid for up to 7 years.
- Requests for exemptions:
- Must be filed with the Commission and include all information listed in Annex V. Most notably, the request must include an analysis of possible alternative substances, materials or designs.
- Renewals must be requested at least 18 months before the existing exemption expires.
The labeling requirements are likely to have been already addressed by MDD or IVDD requirements. However, a review of the requirements in Articles 7.g, 7.h9.d and 10.a will be needed for confirmation.
- Records must be retained for 10 years after a device is placed on the market. Note that this may be longer than required by the MDD 93/42/EEC or IVDD 98/79/EC.
- Records to retain include technical documentation confirming compliance with the RoHS Directive and a register of non-conforming products and product recalls.
What is the Code of Conduct for Notified Bodies?
TEAM-NB is the European Association of Notified Bodies for Medical devices. It is a non-profit organization in which the members are Notified Bodies (EU bodies accredited to certify for CE marking). It has recently published the version 3.0 of the code of conduct for Notified Bodies.
What is the best way of selecting a Notified Body?
Notified Bodies are organizations accredited by national EU competent authorities with the aim of supporting the manufacturer by carrying out conformity assessment procedures and issuing conformity certificates, thus supporting the manufacturer to affix the CE marking to their medical devices. Such conformity procedures and certificates are required under the “New Approach” Directives for medical devices – MDD 93/42/EEC, AIMDD 90/385/EEC and IVDD 98/79/EC.
Are disinfectant products classified as medical devices?
When considering the characteristics of a disinfectant product for the purpose of product classification, manufacturers may conclude that their products fall within the scope of a medical device or an accessory to a medical device.
The MDD 93/42/EEC, Annex IX, rule 15 dictates:
– All devices intended specifically to be used for disinfecting medical devices are in Class IIa. ►M5 Unless they are specifically to be used for disinfecting invasive devices, in which case they are in Class IIb.
How are Products That are Considered Both Medical and Cosmetics Classified?
Summary of the Guidance Document
The “Guidance Document of the Demarcation between the Cosmetic Products Directive 76/768/EEC and the Medicinal Products Directive 2001/83 as agreed between the Commission Services and the Competent Authorities of the EU Member States” document attempts to provide guidance for the classification of products that may simultaneously fulfill the definition of a cosmetic product (as per the 76/768 Directive) as well as the definition of a medicinal product (as per the 2001/83 Directive).
EU Market, Timeline & Harmonization
EU Market Timeline:
1. The European Community (1957)
2. Schengen Visa area (1985)
3. Unified European Market (1992)
4. “New Approach” (1985,1989,1993 & 2010)
5. The Euro born (2002)